Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000389606
Ethics application status
Approved
Date submitted
17/03/2014
Date registered
10/04/2014
Date last updated
23/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intravenous Dexmedetomidine Infusion In Adult Patients Undergoing Open Nephrolithotomy
Scientific title
Intravenous Dexmedetomidine Infusion In Adult Patients Undergoing Open Nephrolithotomy: Effects On Intraoperative Hemodynamics And Blood loss.

Clinical research study
Secondary ID [1] 284274 0
Nil known
Universal Trial Number (UTN)
U1111-1154-5834
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraoperative Hemodynamics 291405 0
Intraoperative Blood loss. 291406 0
Nephrolithotomy 291407 0
Condition category
Condition code
Anaesthesiology 291768 291768 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will randomly allocated using a closed envelop technique into two groups (n= 25).

Group D: will receive a bolus dose of dexmedetomidine (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA) 1ug/kg over 10 min before induction of anesthesia then dexmedetomidine iv infusion of 0.1 ug-0.5ug/kg/h infused continuously throughout the operation. guided by hemodynamics

Group P: will receive a bolus dose of 10 ml ringer solution before induction of anesthesia, and continuous intraoperative infusion 10 ml /h ringer solution
Intervention code [1] 288984 0
Treatment: Drugs
Intervention code [2] 288986 0
Prevention
Comparator / control treatment
Group P: will receive a bolus dose of 10 ml ringer solution before induction of anesthesia, and continuous intraoperative infusion
Control group
Placebo

Outcomes
Primary outcome [1] 291699 0
Heart rate
Timepoint [1] 291699 0
Monitored continuously intraoperative with ECG
Secondary outcome [1] 307324 0
Volume of blood loss:in the suction drain and swabs
Timepoint [1] 307324 0
measured intraoperative
Secondary outcome [2] 307619 0
Number of packed red blood cells transfused
Timepoint [2] 307619 0
measured intraoperative
Secondary outcome [3] 307710 0
Laboratory Hb
Timepoint [3] 307710 0
Pre, intra and immediate post-operative
Secondary outcome [4] 307711 0
Laboratory haematocrite concentration
Timepoint [4] 307711 0
Pre, intra and immediate post-operative

Eligibility
Key inclusion criteria
ASA I and II males and females patients aged 20-60 years old, planned for elective open nephrolithotomy under general anesthesia
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA more than II , had a known cardiac arrhythmias ,significant liver disease defined as (serum alanine aminotransferase and serum aspartate aminotransferase >2.5 times normal),significant renal disease defined as (serum creatinine >1.5 mg/dl or creatinine clearance <40 ml/min),pregnant patient, significant coagulopathy defined as (INR >1.5),use of antiplatlets or anticoagulants ,anemic patients with Hb% less than 10 gm/dl

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study drugs will be prepared by a senior anesthetia resident unaware of the study protocol
Patients will randomly allocated using a closed envelop technique into two groups
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study drugs will be prepared by a senior anesthetia resident unaware of the study protocol
Patients will randomly allocated using a closed envelop technique into two groups
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis:
After a pilot study in ten patients, the mean intraoperative blood loss (SD) was 621 (143) and 782 (338) in the dexmedetomidine group and the placebo group, respectively. Therefore, the sample size was calculated using the program of biostatistics version 3.01 twenty five per group was needed to show a difference of intraoperative blood loss 161 ml (SD 195 ml) between groups with the power was set at 80% and the a-error level was fixed at 0.05.
Data are presented as mean ± standard deviation (SD) or median (range) or numbers as appropriate , Numerical data were analyzed by using Student’s unpaired ttest.Nonparametric data were analyzed by using the Mann
Whitney U-test. A value of P < 0.05 was considered statistically significant.



Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2014
Actual
1/04/2014
Date of last participant enrolment
Anticipated
30/09/2014
Actual
1/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5896 0
Egypt
State/province [1] 5896 0
benisuef

Funding & Sponsors
Funding source category [1] 288901 0
University
Name [1] 288901 0
egypt ,benisuef governerate
benisuef university
mokbel
Country [1] 288901 0
Egypt
Primary sponsor type
Hospital
Name
benisuef university hospital
Address
egypt,

benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511
Country
Egypt
Secondary sponsor category [1] 287595 0
None
Name [1] 287595 0
Address [1] 287595 0
Country [1] 287595 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290733 0
research ethical comittee
Ethics committee address [1] 290733 0
benisuef university faculty of medecine
(FMBSU)
egypt,



-,mokbel,mohamad anwar hassan street, 62511
Ethics committee country [1] 290733 0
Egypt
Date submitted for ethics approval [1] 290733 0
17/03/2014
Approval date [1] 290733 0
25/03/2014
Ethics approval number [1] 290733 0

Summary
Brief summary
Patients and Methods:
After approval of the ethical committee in Beni suef University (FMBUS REC,Egypt) the study was registered at ANZCTR clinical trial registry ,(registration number ACTRN12614000389606),a written informed consents were obtained from 50 patients ASA I and II males and females aged 20-60 years old, scheduled for elective open nephrolithotomy under general anesthesia from March 2014 to September 2014.
Patients were excluded if they were ASA more than II , had a known cardiac arrhythmias, significant liver disease defined as (serum alanine aminotransferase and serum aspartate aminotransferase >2.5 times normal),significant renal disease defined as (serum creatinine>1.5 mg/dl or creatinine clearance <40 ml/min),pregnant patient, significant coagulopathy defined as (INR >1.5),use of antiplatlets or anticoagulants, anemic patients with Hb% less than 10 gm/dl.
In the operating room, two intravenous cannula was inserted , monitors were connected including Electrocardiogram, pulse oximetry, non-invasive arterial blood pressure at 5 minutes intervals and BIS monitor strip (BIS Sensor; Aspect Medical Systems, USA, Toll free 1-888-BIS Index)
The study drugs were prepared by a senior anesthesia resident unaware of the study protocol
Patients were randomly allocated using a closed envelop technique into two groups (n= 25 each).
Group D: received in a separate cannula a bolus dose of dexmedetomidine (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA) 1 micogram/kg over 10 min before induction of anesthesia then iv infusion of 0.1 -0.5 micogram/kg/h guided by the hemodynamics.
Group P: received a bolus dose of 10 ml ringer lactate solution before induction of anesthesia then continuous infusion till the end of the operation.
Preoxgenation for 3- 5 minute with 100% oxygen by facemask, then induction of anesthesia in all patients was with the use of i.v. fentanyl 2 micogram / kg, propofol 2 mg/ kg, , atracurium (0.5mg/kg) and ventilated manually with sevoflorane 2 volume % ,oxygen 100% via a face mask then oral cuffed endotracheal tube was inserted when the BIS value reached (40-60) which indicate optimal hypnotic state , anesthesia was maintained with oxygen 100%, sevoflurane (according to the depth of anesthesia guided by BIS to be between 40%-60%),muscle relaxation was maintained by additional doses of atracurium, guided by peripheral nerve stimulator ( Life-Tech EZstimII), mechanical ventilation with maintenance of end tidal carbon dioxide 36-40mmHg,all patients received 15mg/kg Pefalgan and 2 micogram /kg fentanyl IV. A wide bore IV cannula was also inserted. Hypotension defines as systolic blood pressure less than 90 mmHg was treated by decreasing the dexmedetomidine concentration and or sevoflorane concentration and ephedrine in 3 mg IV increments of needed, bradycardia is defined as heart rate less than 60 beat per minute and was managed by decreasing the dexmedetomidine concentration in D group or atropine 0.5mg IV if needed.

At the end of surgery, 0.25% bupivacaine
was injected by the surgeon at the surgical wound, neuromuscular blockade was reversed with IV neostigmine 0.04mg/kg and atropine 0.02 mg/kg, the trachea was extubated when the patient respond to commands, all patients were transferred to PACU, where they received oxygen via face mask 3-4 L/min and were monitored.
The following parameters were evaluated and recorded by senior anesthesia resident unaware of the study protocol:
1. Patients’s characteristics : age, sex, height, weight, ASA physical status and duration of surgery.

2. Heart rate, systolic and diastolic arterial blood pressure, arterial oxygen saturation (SpO2): before induction, after induction of anesthesia, then every 15 minutes intraoperative.



3. Volume of blood loss (ml) :in the surgical swabs and suction bottle

4. Laboratory Hb and hematocrit concentration :(Pre, intra and immediate post-operative)
5. Number of units PRBCs transfused
6. Urine output (ml)
Trial website
Trial related presentations / publications
paper sent for evalution
Public notes
Attachments [1] 12 12 0 0
/AnzctrAttachments/365983-protocol 2.docx
Attachments [2] 20 20 0 0
/AnzctrAttachments/365983-ethical aproval.docx

Contacts
Principal investigator
Name 46990 0
Dr doaa rashwan
Address 46990 0
doaa rashwan egypt
benisuef governerate mokbel

egypt,

benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511
Country 46990 0
Egypt
Phone 46990 0
+2020822318605
Fax 46990 0
Email 46990 0
[email protected]
Contact person for public queries
Name 46991 0
Dr doaa rashwan
Address 46991 0
doaa rashwan egypt benisuef governerate mokbel
egypt,

benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511
Country 46991 0
Egypt
Phone 46991 0
+20822318605
Fax 46991 0
Email 46991 0
[email protected]
Contact person for scientific queries
Name 46992 0
Dr doaa rashwan
Address 46992 0
doaa rashwan egypt
benisuef governerate


benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511
Country 46992 0
Egypt
Phone 46992 0
+20822318605
Fax 46992 0
Email 46992 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseIntravenous dexmedetomidine infusion in adult patients undergoing open nephrolithotomy: Effects on intraoperative hemodynamics and blood loss; A random ized controlled trial.2015https://dx.doi.org/10.1016/j.egja.2015.03.007
N.B. These documents automatically identified may not have been verified by the study sponsor.