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CTRI Number  CTRI/2022/09/045432 [Registered on: 12/09/2022] Trial Registered Prospectively
Last Modified On: 11/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to check the efficacy of Buprenorphine Patch 10mg in controlling the Blood Pressure and Heart Rate that increases in response to introduction of Laryngoscope and Endotracheal Tube into the airway in patients undergoing Surgery under General Anesthesia 
Scientific Title of Study   Attenuation of stress response to laryngoscopy and intubation with transdermal buprenorphine patch under general anesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preetika Dhall 
Designation  Junior Resident 
Affiliation  Mahatma Gandhi University Of Medical Sciences And Technology 
Address  Junior resident,Department of Anaesthesia Room no 1,Pg Hostel 4 a, Mahatma Gandhi Medical College Campus Riico Industrial Area,Sitapura Jaipur
Room no 1,Pg Hostel 4 a, Mahatma Gandhi Medical College Campus Riico Industrial Area,Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India 
Phone  8396007347  
Fax    
Email  preet25dhall@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vipin Goyal 
Designation  professor 
Affiliation  Mahatma Gandhi University Of Medical Sciences And Technology 
Address  Professor,Department of Anaesthesia Mahatma Gandhi Medical College Riico Industrial Area,Sitapura Jaipur
Faculty quarters Mahatma Gandhi Medical College Riico Industrial Area,Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India 
Phone  8396007347  
Fax    
Email  Dr.vipin28@gmail.com  
 
Details of Contact Person
Public Query  
Name  Preetika Dhall 
Designation  Junior Resident 
Affiliation  Mahatma Gandhi University Of Medical Sciences And Technology 
Address  Junior resident,Department of Anaesthesia, Mahatma Gandhi hospital Riico Industrial Area,Sitapura Jaipur
Room no 1,Pg Hostel 4 a, Mahatma Gandhi Medical College Campus Riico Industrial Area,Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India 
Phone  8396007347  
Fax    
Email  preet25dhall@gmail.com  
 
Source of Monetary or Material Support  
mahatma gandhi university of medical sciences and technology 
 
Primary Sponsor  
Name  Mahatma Gandhi University Of Medical Sciences And Technology 
Address  Mahatma Gandhi Medical College and Hospital Riico Industrial Area,Sitapura Jaipur 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preetika Dhall  Mahatma Gandhi Hospital  Operation Theatre Complex, Department Of Anesthesia
Jaipur
RAJASTHAN 		 8396007347

preet25dhall@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  buprenorphine  buprenorphine patch(10mg) will be applied transdermally once to the patients 12 hours prior to surgery on non-hairy area and will be covered with occlusive dressing by nursing staff. On the day of surgery on arrival in the operation room, standard ASA monitoring will be attached and baseline vitals(sbp,dbp,map,hr,spo2) will be recorded. After securing IV line injection midazolam 1 mg and injection fentanyl 100ug will be administered. Anaesthesia will be induced with injection propofol 2.5 mg/kg slow IV. Laryngoscopy and tracheal intubation will be done 4 minutes after intubating dose of cisatracurium (0.2mg/kg). Vital parameters (systolic blood pressure (SBP), diastolic blood pressure DBP), mean arterial pressure (MAP), heart rate (HR), Oxygen saturation, Electrocardiogram (ECG) will be recorded at 0,1 , 3, 5 and 10 minutes after intubation. Thereafter, monitoring will be continued throughout the surgery every 15 minutes. Any adverse effect like skin hypersensitivity to buprenorphine patch, nausea or vomiting etc. will be recorded, if occurs.  
Comparator Agent  Placebo  placebo patch will be applied transdermally once to the patients 12 hours prior to surgery on non-hairy area and will be covered with occlusive dressing by nursing staff. On the day of surgery on arrival in the operation room, standard ASA monitoring will be attached and baseline vitals will be recorded. After securing IV line injection midazolam 1 mg and injection fentanyl 100ug will be administered. Anaesthesia will be induced with injection propofol 2.5 mg/kg slow IV. Laryngoscopy and tracheal intubation will be done 4 minutes after intubating dose of cisatracurium (0.2mg/kg). Vital parameters (systolic blood pressure (SBP), diastolic blood pressure DBP), mean arterial pressure (MAP), heart rate (HR), Oxygen saturation, Electrocardiogram (ECG) will be recorded at 0,1 , 3, 5 and 10 minutes after intubation. Thereafter, monitoring will be continued throughout the surgery every 15 minutes.Any adverse effect like skin hypersensitivity to buprenorphine patch, nausea or vomiting etc. will be recorded, if occurs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient posted for surgery under general anaesthesia
2. patient with American Society of anaesthesiologists (ASA) Class I and II
3. patient of any sex (male or female) aged between 18-60 years
4. patient who give consent to involve in study 
 
ExclusionCriteria 
Details  ï‚·Patient with American Society of Anaesthesiologists (ASA) Class III and IV
ï‚·Patient allergic to buprenorphine
ï‚·Patients with anticipated difficult intubation (Modified mallapatti score 3 or more)
1.More than one attempt at intubation
2.When intubation time exceeds 30 seconds
3.Patients with severe cardiopulmonary compromise
4.Pregnant female
5.Patients with liver and kidney disease
6.Patient refusal 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to observe any changes in systolic blood pressure after laryngoscopy and intubation.  preoperatively and postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
to observe changes in diastolic blood pressure,mean areterial pressure, and ecg  preoperatively and intraoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [preet25dhall@gmail.com].

  6. For how long will this data be available start date provided 30-09-2022 and end date provided 30-09-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Altered hemodynamic response during laryngoscopy and intubation can cause many complications like left ventricular failure,myocardial infarction and pulonary edema etc.Oral or iv intravenous medications used to prevent stress response have been associated with many undesirable adverse effects like respiratory depression,drowsiness ,nausea and vomiting etc.Rationale for study is that transdermal buprenorphine would attenuate the stress response with no or minimal side effects. 
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