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Trial registered on ANZCTR
Registration number
ACTRN12613000485730
Ethics application status
Approved
Date submitted
29/04/2013
Date registered
1/05/2013
Date last updated
6/05/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
The use of intravenous paracetamol (acetaminophen) infusion before the start of general anesthesia with spectral entropy monitoring decreases consumption of the inhalational anesthetic sevoflurane in patients undergoing thyroidectomy surgery.
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Scientific title
Preoperative paracetamol (acetaminophen) infusion reduces sevoflurane consumption during thyroidectomy under general anesthesia with spectral entropy monitoring
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Secondary ID [1]
282406
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
anesthesiology for thyroidectomy.
288988
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Condition category
Condition code
Anaesthesiology
289329
289329
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Before the start of anesthesia, the patients were randomized, by using a computer generated random list to one of two groups; the Paracetamol group (Group P) and the Control group (Group C). All patients received a slow IV infusion over 15 min just before induction of anesthesia of either 1 gm paracetamol (Perfalgan 10 mg ml-1, 100 ml vial; UPSA, France) (Group P, n=31) or 100 ml of normal saline (Group C, n=31). Extubation time, time to eye opening to command, time to state his/her name and time to correctly mention his/her date of birth (assessed at 60 sec intervals) were noted and taken from cessation of sevoflurane inhalation. Sevoflurane consumption was estimated for each patient. Pain intensity was assessed immediately by the nurses who were blinded to the treatment group using a VAS, and was re-assessed again before leaving the PACU after 30 min, then in the surgical ward, every 30 min till the end of the 6th PO hour
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Intervention code [1]
287039
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Treatment: Drugs
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Comparator / control treatment
100 ml of normal saline
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The primary outcome of this study was the sevoflurane end-tidal concentration which was recorded from the anesthesia monitor at regular interval throughout the operation and the sevoflurane consumption in the 2 groups, which was estimated by the “vaporizer weighing method” in which the vaporizer was filled to maximum and weighed before induction of anesthesia, then reweighed again at the completion of surgery. By knowing the specific weight of sevoflurane (1.52 kg L-1)16; the volume of the consumed liquid sevoflurane was estimated.
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Assessment method [1]
289443
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Timepoint [1]
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at the end of surgery
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Secondary outcome [1]
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extubation time, the time interval from cessation of sevoflurane inhalation to tracheal extubation
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Assessment method [1]
302486
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Timepoint [1]
302486
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after completion of surgery
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Secondary outcome [2]
302536
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postoperative pain score by using a visual analogue scale (VAS)
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Assessment method [2]
302536
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Timepoint [2]
302536
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Pain intensity was assessed immediately on admission to PACU by the nurses who were blinded to the treatment group using a VAS, and was re-assessed again before leaving the PACU after 30 min, then in the surgical ward, every 30 min till the end of the 6th PO hour.
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Eligibility
Key inclusion criteria
ASA physical status I and II patients of both sex, scheduled for subtotal thyroidectomy under general anesthesia.
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Minimum age
20
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
known allergy to paracetamol, neurological or psychological diseases, impaired liver functions (ALT > twice the normal value) and impaired renal function (serum creatinine >2.0 mg %). Exclusion criteria also included pregnancy and breast feeding, the chronic use of analgesics or drugs affecting the central nervous system (CNS) function, the use of paracetamol within 6 hours or any other analgesic medication within 12 hours before the operation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
7/05/2011
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Actual
7/05/2011
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Date of last participant enrolment
Anticipated
26/02/2013
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Actual
26/02/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
62
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5049
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Saudi Arabia
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State/province [1]
5049
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Funding & Sponsors
Funding source category [1]
287178
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Self funded/Unfunded
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Name [1]
287178
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dr. waleed m abdelmageed
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Address [1]
287178
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King Abdulaziz Naval Base Hospital, Jubail 31951, Saudi Arabia
PO Box413
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Country [1]
287178
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Saudi Arabia
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Primary sponsor type
Individual
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Name
dr. waleed m abdelmageed
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Address
King Abdulaziz Naval Base Hospital, Jubail 31951, Saudi Arabia
PO Box413
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Country
Saudi Arabia
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Secondary sponsor category [1]
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None
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Name [1]
285943
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Address [1]
285943
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Country [1]
285943
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289174
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Research and Ethics Committee, King Abdulaziz Naval Base Hospital.
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Ethics committee address [1]
289174
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King Abdulaziz Naval Base Hospital, Jubail 31951, Saudi Arabia
PO Box413
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Ethics committee country [1]
289174
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Saudi Arabia
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Date submitted for ethics approval [1]
289174
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16/04/2011
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Approval date [1]
289174
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16/04/2011
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Ethics approval number [1]
289174
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Summary
Brief summary
Proper monitoring of the depth of anesthesia is crucial for judicious titration of anesthetics to prevent awareness under general anesthesia as well as the side effects of anesthetic over-dose with the subsequent economic waste and environmental pollution. With awareness, the patient may exhibit symptoms ranging from mild anxiety to post traumatic stress disorder (sleep disturbances, nightmares and social difficulties). In the standard clinical practice, the depth of anesthesia is judged by the clinical experience of the anesthetist based on the patient’s vital signs and the hemodynamic responses. However the regular use of certain medications as beta-blockers and antihypertensive drugs render the hemodynamic signs unreliable for titration of anesthetics.
At present; the electroencephalogram (EEG) based spectral entropy is increasingly being used for monitoring the depth of anesthesia and provides information regarding the cortical state of the patient and the level of hypnosis as well as an indirect measure of the adequacy of analgesia. The monitor uses different algorithms to calculate the level of consciousness index by processing the EEG signal measured over the forehead and drive the numeric index. The spectral entropy has 2 signals: State entropy (SE) which reflects the hypnotic level of the patient; computed from an EEG data from the previous 15 sec in the range of 0.8 to 32 Hz, and shows the value in the range of 0 – 91 and Response entropy (RE) that includes; in addition to the EEG, a forehead muscle electromyography component and reflects the patient arousal and response to painful stimuli. The latter is computed from an EEG data in the range of 0.8 to 47 Hz and shows the value in the range of 0 – 100. Entropy values between “40 – 60” are the recommended surgical level of anesthesia while “100” signifies awake state and “0” indicates suppression of the cortical neuronal activity.
Intravenous (IV) paracetamol (acetaminophen in USA) is an effective analgesic and antipyretic agent acting at both the central and peripheral components of the pain pathway and devoid of the detrimental effects of opioids and non-steroidal anti-inflammatory drugs (NSAID) with a tolerability profile similar to placebo. The onset of paracetamol analgesia starts rapidly after 5 – 10 min of IV administration, with peak effect obtained within 1 hour and lasting 4 – 6 hours. Thus, IV paracetamol is a suitable medication for the treatment of postoperative pain when used either alone or as a part of a balanced analgesic regimen. In addition, several studies in the medical literature have demonstrated the opioid-sparing effect of IV paracetamol. In view of these reports, we hypothesized that preoperative infusion of IV paracetamol would decrease sevoflurane consumption during general anesthesia. To explore this; we utilized spectral entropy monitoring to evaluate the effect of the preoperative administration of IV paracetamol on sevoflurane consumption in patients undergoing thyroidectomy under general anesthesia.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Waleed M. Abdelmageed
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Address
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King Abdulaziz Naval Base Hospital, Jubail 31951
PO Box 413
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Country
39602
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Saudi Arabia
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Phone
39602
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+966557189366
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Fax
39602
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Email
39602
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[email protected]
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Contact person for public queries
Name
39603
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A/Prof Waleed M. Abdelmageed
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Address
39603
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King Abdulaziz Naval Base Hospital, Jubail 31951
PO Box 413
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Country
39603
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Saudi Arabia
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Phone
39603
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+966557189366
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Fax
39603
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Email
39603
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Waleed M. Abdelmageed
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Address
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King Abdulaziz Naval Base Hospital, Jubail 31951
PO Box 413
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Country
39604
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Saudi Arabia
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Phone
39604
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+966557189366
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Fax
39604
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Email
39604
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
Preoperative paracetamol infusion reduces sevoflurane consumption during thyroidectomy under general anesthesia with spectral entropy monitoring
2014
https://doi.org/10.1016/j.egja.2013.12.003
N.B. These documents automatically identified may not have been verified by the study sponsor.
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