Trial Review

This is a test website


Please note the ANZCTR will be unattended on Monday the 27th of January due to the national public holiday.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000061437
Ethics application status
Approved
Date submitted
4/11/2024
Date registered
21/01/2025
Date last updated
21/01/2025
Date data sharing statement initially provided
21/01/2025
Date results provided
21/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison Of The Effects Of Propofol-Dexmedetomidine And Thiopental-Dexmedetomidine Combinations On The Success Of Classical Laryngeal Mask Airway Insertion
Scientific title
Comparison Of The Effects Of Propofol-Dexmedetomidine And Thiopental-Dexmedetomidine Combinations On The Success Of Classical Laryngeal Mask Airway Insertion, Hemodynamic Response And Pharyngolaryngeal Morbidity in participants undergoing elective surgery.
Secondary ID [1] 313309 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anesthesiology 335657 0
airway management 335658 0
Condition category
Condition code
Anaesthesiology 332222 332222 0 0
Anaesthetics
Anaesthesiology 332572 332572 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 80 patients aged 18–65 years with ASA I-II physical status undergoing elective surgery with LMA insertion were included. Muscle relaxants were not used, and surgeries were limited to less than 2 hours. Patients with neck or upper respiratory pathologies, difficult airway history, morbid obesity, lung disease, or chronic sedative/opioid use were excluded.

All patients underwent standard monitoring (HR, SAP, DAP, MAP, ECG, and SpO2) prior to anesthesia induction. Anesthesia depth was measured using bispectral index (BIS) monitoring. A 20G IV cannula was inserted, and 7 mL·kg saline infusion was administered.

Group P (Control Group): 2 µg/kg remifentanil followed by 2.5 mg/kg propofol.
Group T (Intervention Group): 2 µg/kg remifentanil followed by 5 mg/kg thiopental.
After induction, the LMA was inserted 90 seconds later when BIS was <40 and jaw relaxation was sufficient. Placement was performed by a single, experienced researcher using the standard technique, and cuff pressure was maintained at 60 cmH2O.

Assessment of LMA Insertion:
Conditions for LMA insertion were evaluated during the first attempt only using a 6-variable scale (jaw opening, ease of insertion, swallowing, coughing, laryngospasm, and movement). Insertion conditions were rated as:

Optimal: All criteria were excellent.
Acceptable: A mix of excellent and good criteria.
Poor: At least one poor criterion.
Monitoring Adherence to the Intervention:

Drug preparation and administration were conducted using blinded syringes.
A researcher independent of the anesthesia process monitored LMA placement conditions and patient responses.
Adherence was ensured through detailed documentation of drug dosages, LMA attempts, and peroperative parameters.
Perioperative and Postoperative Outcomes:
SAP, DAP, MAP, HR, BIS, and SpO2 were recorded 1 minute before and at 1, 2, 3, 4, and 5 minutes after LMA insertion. Apnea duration, defined as the time from the last spontaneous breath after induction to the first spontaneous breath, was recorded.

Postoperatively, patients were evaluated for:

Sore Throat: Rated on a 0–3 scale (none, mild, moderate, severe).
Dysphagia: Presence or absence determined by difficulty swallowing water.
Blood Presence on LMA: Graded as none, trace, or significant.
Hypotension (MAP <30% below baseline) was treated with 6 mg of ephedrine, and bradycardia (HR <50 bpm) was treated with 0.5 mg IV atropine.
Intervention code [1] 329883 0
Treatment: Drugs
Comparator / control treatment
Control Group (Group P):
Patients in Group P received 1 µg/kg dexmedetomidine infused over 10 minutes using an infusion pump (Braun Infusomat®) followed by 2.5 mg/kg propofol.

Induction Process:

The first syringe contained 1 µg/kg dexmedetomidine diluted with saline to a total of 50 mL.
The second syringe contained 20 mL of 1% propofol (10 mg·mL) and was covered with opaque tape to ensure blinding.
Three minutes before induction, patients were premedicated with 0.03 mg/kg IV midazolam.
A fixed dose of propofol (0.25 mL/kg) was infused over 30 seconds during the last 30 seconds of the dexmedetomidine infusion.
Blinding and Fidelity Monitoring:

Syringes were prepared by a nurse not involved in the study to ensure a double-blind protocol.
Drug administration was performed by a resident behind a drape, keeping the anesthesiologist inserting the LMA and monitoring parameters blind to the administered drug.
Assessment:

LMA insertion conditions, hemodynamic parameters, and postoperative pharyngolaryngeal morbidity were evaluated.
Adherence to the intervention protocol was monitored through anesthesia records, timing of drug administration, and blinded assessment of outcomes.
Control group
Active

Outcomes
Primary outcome [1] 339797 0
LMA placement conditions
Timepoint [1] 339797 0
LMA placement conditions were assessed immediately after insertion, following the standard method described by Brain. The evaluation was conducted using a 6-variable scale.
Secondary outcome [1] 441381 0
Frequency and severity of pharyngolaryngeal complications
Timepoint [1] 441381 0
After removing the LMA, the presence of blood was assessed on a scale of 1–3 (none, trace, significant). To determine the frequency and severity of pharyngolaryngeal complications, all patients were evaluated once, at discharge from the recovery unit, for sore throat (constant pain, independent of swallowing) and dysphagia (difficulty swallowing provoked by drinking) by a single blinded researcher.

Eligibility
Key inclusion criteria
A total of 80 patients who were between the ages of 18 and 65 years, were in class I-II according to the American Society of Anesthesiologists (ASA) physical status classification system, were undergoing elective surgery not exceeding 2 hours in duration, did not require muscle relaxant, and had indication for LMA insertion were included in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with any of the following were excluded: neck or upper respiratory tract pathology, sore throat, dysphagia, or dysphonia; history or risk factors for difficult airway (Mallampati class 3-4, sternomental distance less than 12 cm, thyromental distance less than 6 cm, head extension less than 90 degrees, mouth opening less than 1.5 cm); morbid obesity; or history of lung disease, alcohol or substance addiction, chronic sedative or opioid analgesic use, or allergy to the study drugs.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
1/04/2014
Date of last data collection
Anticipated
Actual
1/04/2014
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 26672 0
Turkey
State/province [1] 26672 0

Funding & Sponsors
Funding source category [1] 317756 0
Hospital
Name [1] 317756 0
Okmeydani Education and Research Hospital
Country [1] 317756 0
Turkey
Primary sponsor type
University
Name
Firat University Faculty of Medicine
Address
Country
Turkey
Secondary sponsor category [1] 320077 0
None
Name [1] 320077 0
Address [1] 320077 0
Country [1] 320077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316447 0
Okmeydani Egitim ve arastirma Hastanesi Klinik Arastirmalar Etik Kurulu
Ethics committee address [1] 316447 0
Ethics committee country [1] 316447 0
Turkey
Date submitted for ethics approval [1] 316447 0
03/09/2013
Approval date [1] 316447 0
24/09/2013
Ethics approval number [1] 316447 0
109 - 03/09/2013

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137918 0
Mrs Mensure Cakirgoz
Address 137918 0
University of Health Sciences, Izmir Tepecik Training and Research Hospital, Department of Anesthesiology and Reanimation, Intensive Care Unit, Izmir,(post code:34384)
Country 137918 0
Turkey
Phone 137918 0
+905066906977
Fax 137918 0
Email 137918 0
[email protected]
Contact person for public queries
Name 137919 0
Mensure Cakirgoz
Address 137919 0
University of Health Sciences, Izmir Tepecik Training and Research Hospital, Department of Anesthesiology and Reanimation, Intensive Care Unit, Izmir (post code:34384)
Country 137919 0
Turkey
Phone 137919 0
+905066906977
Fax 137919 0
Email 137919 0
[email protected]
Contact person for scientific queries
Name 137920 0
Mensure Cakirgoz
Address 137920 0
University of Health Sciences, Izmir Tepecik Training and Research Hospital, Department of Anesthesiology and Reanimation, Intensive Care Unit, Izmir, (post code:34384)
Country 137920 0
Turkey
Phone 137920 0
+905066906977
Fax 137920 0
Email 137920 0
[email protected]

Data sharing statement
Will sharing of individual participant data from this study be considered?
No
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24312Ethical approval    388715-(Uploaded-04-11-2024-18-57-50)-CamScanner 15.09.2024 15.57.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.