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CTRI Number  CTRI/2024/06/069669 [Registered on: 28/06/2024] Trial Registered Prospectively
Last Modified On: 27/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Sedation with two different drugs and postoperative recovery in patients undergoing Endoscopic Retrograde Cholangiopancreatography 
Scientific Title of Study   Comparison between Dexmedetomidine and Magnesium sulphate as adjuvants to propofol for postoperative recovery in patients undergoing Endoscopic Retrograde Cholangiopancreatography under Monitored Anaesthesia Care A Randomised Comparative Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr S N medical collage Jodhpur 
Address  123 Vaishali avenue Jhanwar road Jodhpur
Main OT Complex First floor Department of Anaesthesia MDM Hospital Dr S N medical collage Jodhpur RAJASTHAN 342001
Jodhpur
RAJASTHAN
342008
India 
Phone  9414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alisha P V  
Designation  Junior Resident 
Affiliation  Dr S N medical collage Jodhpur 
Address  Main OT Department of Anaesthesia First Floor MDM hospital Dr S N medical collage Jodhpur Rajasthan 342001
Main OT Department of Anaesthesia First Floor MDM hospital Dr S N medical collage Jodhpur Rajasthan 342001
Jodhpur
RAJASTHAN
342001
India 
Phone  7356377155  
Fax    
Email  alishapv96@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr S N medical collage Jodhpur 
Address  MDM hospital Dr S N Medical Collage Jodhpur
Main OT Complex First floor Department of Anaesthesia MDM Hospital Dr S N medical collage Jodhpur RAJASTHAN 342001
Jodhpur
RAJASTHAN
DrGeeta Singariya
India 
Phone  9414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Source of Monetary or Material Support  
MDM Hospital Dr S N Medical Collage Jodhpur RAJASTHAN 342001  
 
Primary Sponsor  
Name  M D M Hospital Dr S N Medical College Jodhpur  
Address  First floor Main operation theater MDM Hospital Dr S N Medical College Shastri Nagar Jodhpur Rajasthan 342001 
Type of Sponsor  Government 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 
DrGeeta Singariya  MDM hospital, Dr S N Medical collage, Jodhpur  OT Complex Third floor Department of anesthesia M D M Hospital Dr S N Medical College Shastri Nagar Dr S N medical collage, Jodhpur Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 		 9414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr S N Medical College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Dexmedetomidine 1 mcg/kg IV as a bolus in 100 ml of 0.9% normal saline over 10 minutes, followed by propofol loading dose of 0.25mg/kg and 10 mg supplementary dose till RSS 4  
Comparator Agent  Magnesium sulphate  Magnesium sulphate 50 mg/kg IV as a bolus in 100 ml of 0.9% normal saline over 10 minutes, followed by propofol loading dose of 0.25mg/kg and 10 mg supplementary dose till RSS 4  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The adult patients, aged 18 to 60 years of both genders, belong to ASA PS I and II, undergoing ERCP under Monitored anaesthesia care. 
 
ExclusionCriteria 
Details  1. Patient refusal
2. History of any allergy to related medications
3. Patients receiving magnesium sulphate supplementation
4. Patients with psychiatric history, myopathy, neurological disease and other comorbidities.
5. Pregnant woman
6. Procedure time greater than 60 minutes
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare quality of postoperative recovery from anesthesia in terms of modified Aldrete score in patients undergoing endoscopic retrograde cholangiopancreatography under monitored anesthesia care with dexmedetomidine and magnesium sulphate as adjuvants to propofol  120 mins 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic monitoring
Total propofol consumption
Ramsay sedation score
Postprocedural VAS score
Complications
Surgeon satisfaction
Patient satisfaction using Likert score
 		 24 Hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 4 
Date of First Enrollment (India)   08/07/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 01-07-2030?
    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   This study will be conducted in the Department of Anaesthesiology in DR S N Medical College and the associated group of hospitals. To ensure inclusion in the study, each patient will be subjected to a detailed pre-anaesthetic evaluation based on detailed history from patients/attenders, thorough physical examination, and pre-anaesthetic airway assessment. Baseline investigations will be done in all the patients to rule out any abnormalities. The purpose and detailed procedure will be explained to the patients. Written informed consent will be taken from all the patients about the procedure. All patients will be kept nil by mouth as per standard guidelines before the scheduled time of surgery.

The patient’s NBM status will be confirmed before the scheduled time of surgery. After arrival to the operating room, routine parameters like heart rate, ECG, pulse oximetry and non-invasive blood pressure will be recorded (for the baseline values). The intravenous line will be secured using an 18/20 G IV cannula and Inj. Ringer Lactate will be started slowly. 

The randomization will be done on a computer-generated random number chart using block randomization (1:1) and allocation concealment will be done by an opaque, sealed envelope method opened during pre-anesthetic checkup. All patients will be randomly allocated into two groups, Group D (dexmedetomidine and propofol) and Group M (magnesium sulphate and propofol).

 
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