| CTRI Number |
CTRI/2025/04/085627 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparison of efficacy of intrathecal Dexmedetomidine versus Morphine |
|
Scientific Title of Study
|
To compare the efficacy of intrathecal Dexmedetomidine versus intrathecal Morphine in patients undergoing Total Laparoscopic Hysterectomy under general anesthesia -A Randomized 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 |
Dr Mohini singh |
| Designation |
junior resident |
| Affiliation |
IGMC Shimla |
| Address |
Department of Anaesthesia
IGMC shimla
Himachal pradesh
Shimla
HIMACHAL PRADESH
171002
India |
| Phone |
07018145735 |
| Fax |
|
| Email |
singhmohini28jan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohini singh |
| Designation |
junior resident |
| Affiliation |
IGMC Shimla |
| Address |
Indira Gandhi Medical College Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
07018145735 |
| Fax |
|
| Email |
singhmohini28janl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kartik Syal |
| Designation |
Associate Professor |
| Affiliation |
IGMC Shimla |
| Address |
Department of Anaesthesia
Indira Gandhi Medical College Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418485155 |
| Fax |
|
| Email |
kartik.syal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Indira Gandhi Medical College shimla , Himachal Pradesh pin code-171001 , India |
|
|
Primary Sponsor
|
| Name |
Dr Mohini singh |
| Address |
INDIRA GANDHI MEDICAL COLLEGE, SHIMLA , HIMACHAL PRADESH
PIN -1710001, INDIA |
| Type of Sponsor |
Other [self] |
|
|
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 Mohini singh |
Indira Gandhi Medical college Shimla |
Kamla Nehru Hospital
Department of Obstetrics and Gynaecology
Shimla
HIMACHAL PRADESH |
07018145735
singhmohini28jan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IGMC, shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N889||Noninflammatory disorder of cervixuteri, unspecified, (2) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
patients in which no intervention was done |
| Intervention |
Dexmedetomidine vs Morphine
|
route of administration- intrathecal
dexmedetomidine dose- 5microgram
morphine dose -200microgram
duration - comparison of post-op efficacy of 2 groups in 24hours |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing elective total laparoscopic hysterectomy under general anesthesia
ASA1-2 patients
|
|
| ExclusionCriteria |
| Details |
patient refusaL to participate
duration of surgery more than 2 hours
known hypersenstivity to local anaesthetic
infection at site of intervention
patient on anticoagulant therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of postoperative analgesia of intrathecal dexmedetomidine versus intrathecal morphine w.r.t duration of analgesia and post-op VAS scores |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate surgeon satisfaction score on basis of operative field and peri-operative experience as whole
2 to note any adverse event in 24hours
3 to evaluate patient satisfaction score |
1year |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Since , not much data regarding efficacy of intrathecal morphine and dexmedetomidine is available in total laparoscopic hysterectomy patients . Hence, we decided to compare the post-operative analgesic efficacy of intrathecal morphine and dexmedetomidine. |