| CTRI Number |
CTRI/2025/08/093471 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study between Dexmedetomidine and Esmolol in keeping heart rate and blood pressure stable during gall bladder surgery using laparoscopic method under general anesthesia. |
|
Scientific Title of Study
|
A comparative evaluation between Dexmedetomidine and Esmolol for hemodynamic responses to pneumoperitoneum during laparoscopic cholecystectomy under general anesthesia in a tertiary care hospital in Sikkim- A double blinded randomized controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Awantika Rai |
| Designation |
Junior Resident |
| Affiliation |
Sikkim Manipal Institute of Medical Science |
| Address |
Department classroom, Level 6,
Department of Anesthesia, Central Referral Hospital, 5th Mile Tadong, Gangtok, East Sikkim
East
SIKKIM
737102
India |
| Phone |
8101799036 |
| Fax |
|
| Email |
awantika97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meyong Pincho Bhutia |
| Designation |
Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Science |
| Address |
Department classroom, Level 6,
Department of Anesthesia, Central Referral Hospital, 5th Mile Tadong, Gangtok, East Sikkim
Department classroom, Level 6,
Department of Anesthesia, Central Referral Hospital, 5th Mile Tadong, Gangtok, East Sikkim
East
SIKKIM
737102
India |
| Phone |
9614389839 |
| Fax |
|
| Email |
meyong.b@smims.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Awantika Rai |
| Designation |
Junior Resident |
| Affiliation |
Sikkim Manipal Institute of Medical Science |
| Address |
Department classroom, Level 6,
Department of Anesthesia, Central Referral Hospital, 5th Mile Tadong, Gangtok, East Sikkim
East
SIKKIM
737102
India |
| Phone |
8101799036 |
| Fax |
|
| Email |
awantika97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia Central Referral Hospital, 5th Mile Tadong,Gangtok,Sikkim. |
|
|
Primary Sponsor
|
| Name |
Sikkim Manipal Institute of Medical Science |
| Address |
Department of Anesthesia, Central Referral hospital, 5th Mile Tadong, Gangtok, Sikkim. PIN 737102 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Awantika Rai |
Central Referral Hospital |
Department classroom, level 6, Department of Anesthesia, 5th Mile Tadong, Gangtok, Sikkim
East
SIKKIM |
8101799036
awantika97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A Randomized control parallel group trail.A comparative evaluation between Dexmedetomidine and Esmolol for hemodynamic responses to pneumoperitoneum during laparoscopic cholecystectomy under general anesthesia. |
Once incision is made on the skin to create pneumoperitoneum, infusion of said drugs- Dexmedetomidine or Esmolol will be started. Heart rate, systolic blood pressure, diastolic blood pressure, and oxygen saturation will be recorded before the initiation of pneumoperitoneum and every 3 minutes after the pneumoperitoneum is established for the first 15 minutes, then every 15 minutes for the 1st hour and every 30 minutes for the next 2 hours or until the pneumoperitoneum ends. |
| Comparator Agent |
A Randomized control parallel group trail.A comparative evaluation between Dexmedetomidine and Esmolol for hemodynamic responses to pneumoperitoneum during laparoscopic cholecystectomy under general anesthesia. |
Once incision is made on the skin to create pneumoperitoneum, infusion of said drugs- Dexmedetomidine or Esmolol will be started. Heart rate, systolic blood pressure, diastolic blood pressure, and oxygen saturation will be recorded before the initiation of pneumoperitoneum and every 3 minutes after the pneumoperitoneum is established for the first 15 minutes, then every 15 minutes for the 1st hour and every 30 minutes for the next 2 hours or until the pneumoperitoneum ends. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & ASA 2 |
|
| ExclusionCriteria |
| Details |
Refusal to participate
ASA 3 & ASA 4
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of two study drugs, Dexmedetomidine and Esmolol in attenuating hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation) during pneumoperitoneum for patients undergoing laparoscopic cholecystectomy under general anesthesia. |
At the time of giving study drug then initiation of pneumoperitoneum and every 3 minutes after the pneumoperitoneum is established and for the first 15 minutes, then every 15 minutes for the first hour and every 30 minutes for the next 2 hours or until the pneumoperitoneum ends. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Using Dexmedetomidine will reduce the chances of using any additional analgesic use. |
During initiation of penumoperitoneum,every 3 minutes after the pneumoperitoneum is established and for the first 15 minutes, then every 15 minutes for the first hour and every 30 minutes for the next 2 hours or until the pneumoperitoneum ends. |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
A comparative evaluation between Dexmedetomidine and Esmolol for hemodynamic responses to pneumoperitoneum during Laparoscopic cholecystectomy under general anesthesia. This research study aims to find out which medicines, i.e. Dexmedetomidine or Esmolol works better in keeping the heart rate, blood pressure, and oxygen levels stable when gas is pumped into the abdominal cavity during gallbladder surgery done under general anesthesia. |