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CTRI Number  CTRI/2024/04/066383 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of regional anesthesia with intravenous dexmedetomidine for decrease in heart rate and blood pressure in laparoscopic cholecystectomy. 
Scientific Title of Study   Comparison of thoracic segmental spinal anesthesia with intravenous dexmedetomidine for haemodynamic responses in laparoscopic cholecystectomy-a randomised controlled 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  Bhavna sriramka 
Designation  ASSOCIATE PROFESSOR 
Affiliation  IMS AND SUM HOSPITAL 
Address  Anesthesia department first floor IMS and sum hospital odisha
cosmopolis road, dumduma
Khordha
ORISSA
751019
India 
Phone  09406033609  
Fax    
Email  bhavna.sriramka@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhavna sriramka 
Designation  ASSOCIATE PROFESSOR 
Affiliation  IMS AND SUM HOSPITAL 
Address  anesthesia department first floor IMS and sum hospital bhubaneswar
cosmopolis road, dumduma

ORISSA
751019
India 
Phone  09406033609  
Fax    
Email  bhavna.sriramka@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhavna sriramka 
Designation  ASSOCIATE PROFESSOR 
Affiliation  IMS AND SUM HOSPITAL 
Address  anesthesia department first floor IMS and sum hospital bhubaneswar
cosmopolis road, dumduma

ORISSA
751019
India 
Phone  09406033609  
Fax    
Email  bhavna.sriramka@gmail.com  
 
Source of Monetary or Material Support  
IMS AND SUM HOSPITAL Bhubaneswar Odisha India 751003 
 
Primary Sponsor  
Name  IMS AND SUM HOSPITAL 
Address  K8, Kalinga Nagar Bhubaneswar, Odisha, India Pin Code – 751003.  
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 Bhavna sriramka  IMS and sum hospital  Anesthesia department First floor Bhubaneswar 751003
Khordha
ORISSA 		 9406033609

bhavna.sriramka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICS COMMITEE, INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  INRAVENOUS DEXMEDETOMIDINE  INRAVENOUS DEXMEDETOMIDINE AT A LOADING DOSE OF 1 MCG/KG FOLLOWED BY 0.5MCG/KG WILL BE STARTED BEFORE INDUCTION OF ANAESTHESIA 
Intervention  THORACIC SEGMENTAL SPINAL ANESTHESIA WITH ROPIVACAINE  THORACIC SEGMENTAL SPINAL ANESTHESIA BY INJECTION ROPIVACAINE 0.2% 1.5 ML BEFORE INDUCTION OF GENERAL ANESTHESIA GIVEN TO PATIENTS UNDERGOING LAPAROSCOPY CHOLECYSTECTOMY 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  PATIENTS UNDERGOING LAPAROSCOPY CHOLECYSTECTOMY
ASA 1 AND 2 
 
ExclusionCriteria 
Details  associated systemic comorbidities like cardiovascular diseases, respiratory diseases, renal diseases, pregnant or lactating mother or any medications like beta blockers, anti-arrhthmics, antipsychotics or steroids. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean blood pressure, heart rate  at baseline, trocar insertion, pneumperitoneum 5 minutes (P5) , 10 minutes (P10), 15 minutes (P15), 30 minutes (P30). 5 minutes after the release of CO2 (R5), and 5 minutes after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
The overall quality of intraoperative muscle relaxation (poor, fair, good, or excellent) was evaluated by the surgeon at the end of the surgery.
Intraoperative requirement of muscle relaxation according to TOF
Rescue analgesic requirement (fentanyl 0.5 mcg/kg)
hypotension, bradycardia 		 DURING AND END OF SURGERY 
 
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 3 
Date of First Enrollment (India)   10/05/2024 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Laparoscopy has now become the standard technique of choice for cholecystectomy. The hallmark of laparoscopy is the creation of pneumoperitoneum which leads to stimulation of the sympathetic nervous system characterised by increase in arterial pressure and systemic and pulmonary vascular resistance with change in heart rate (HR).

Dexmedetomidine is used for blunting the stress responses during critical events such as laryngoscopy, endotracheal intubation, pneumoperitoneum creation, and extubation. Thoracic segmental spinal anesthesia is better with general anesthesia  due to good abdominal relaxation, good hemodynamic stability  alongwith decreased requirement of muscle relaxant and better extubating conditions.

 
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