| CTRI Number |
CTRI/2025/11/097505 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
15/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to compare the effects of Intravenous use of Dexmedetomidine versus Saline Intra-Operatively on Recovery of Gastro - Intestinal Function after Elective Gynaecological Surgeries under Spinal Anaesthesia.
|
|
Scientific Title of Study
|
A Randomized Controlled Study to compare the effects of Intravenous administration of
Dexmedetomidine versus Normal Saline Intra-Operatively on Recovery of Gastro-
Intestinal Motility after Elective Gynaecological Surgeries under Spinal Anaesthesia at
Sawai Man Singh Medical College, Jaipur. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nihar Sharma |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia Sawai Man Singh Medical College |
| Address |
Department of Anaesthesia, second floor Dhanavantri. Sawai Man Singh Medical College, Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9314044376 |
| Fax |
|
| Email |
drniharsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nihar Sharma |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia Sawai Man Singh Medical College |
| Address |
Department of Anaesthesia, second floor Dhanavantri. Sawai Man Singh Medical College, Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9314044376 |
| Fax |
|
| Email |
drniharsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashant Mathuria |
| Designation |
Junior Resident Doctor |
| Affiliation |
Department of Anaesthesia Sawai Man Singh Medical College |
| Address |
Department of Anaesthesia,Sawai Man Singh Medical College and attached hospitals Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8559992248 |
| Fax |
|
| Email |
Prashantmathuria51@outlook.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,Sawai Man Singh Medical College and attached hospitals Jaipur Rajasthan 302004 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Department of Anaesthesia Sawai Man Singh Medical College and attached hospitals Jaipur Rajasthan 302004. |
| Type of Sponsor |
Government 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 |
| Prashant Mathuria |
Obstetric and Gynaecological operation theatre |
Department of Anaesthesia,Sawai Man Singh Medical College and attached Hospitals Jaipur Rajasthan 302004.
Jaipur
RAJASTHAN |
8559992248
Prashantmathuria51@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| OFFICE OF THE ETHICS COMMITTEE,S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR |
Approved |
| OFFICE OF THE ETHICS COMMITTEE,S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Dexmedetomidine. |
Intravenous (IV) Dexmedetomidine 0.5 ug/kg in 100 ml of Normal Saline for 1st 10 minutes as the loading dose.
For maintenance - Dexmedetomidine 0.5 ug/kg in 100 ml of Normal Saline will be given intravenous (IV) over the next 1 hour and same will be repeated for consecutive hours. |
| Comparator Agent |
Injection Normal Saline. |
Intravenous (IV) Normal Saline (For Loading and Maintenance Dose – Patients will be given equivalent amount of normal saline over the same duration.) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Female patients.
Gynaecological surgeries.
Age 18-60years.
Surgery duration less than 2hours.
American Society of Anaesthesiologist classification 1to 3. |
|
| ExclusionCriteria |
| Details |
Contra indication for Spinal Anaesthesia.
Patients with history of Gastrointestinal dysfunction.
Patients with severe bradycardia or hypotension.
Patients with history of allergy to Dexmedetomidine and related ingredients.
Patients with evidence of any liver or kidney disease.
Patients with haemostatic disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean time to first post operative bowel sounds.
Mean time to first post operative faeces |
At 6 Hours post surgery.
At 12 Hours post surgery.
At 24 Hours post surgery.
At 48 Hours post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean VAS score for pain.
Mean Modified Ramsay Sedation Score.
Proportion of complications. |
At 6 Hours post surgery.
At 12 Hours post surgery.
At 24 Hours post surgery.
At 48 Hours post surgery. |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
30/11/2025 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
To compare the effects of intravenous administration of Dexmedetomidine versus Normal Saline intra-operatively on recovery of gastro-intestinal motility after elective gynaecological surgeries under spinal anaesthesia. Randomization will be done by computer generated technique and will be allocated into the groups by seal envelop method. DATA COLLECTION Time to the first post-operative faeces Time to first Bowel sounds VAS Score for satisfaction VAS score for pain assessment Modified Ramsay Score for sedation . |