| CTRI Number |
CTRI/2024/02/062875 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Fentanyl and Midazolam with Bupivacaine in controlling nausea and vomiting in patients undergoing below waist surgeries. |
|
Scientific Title of Study
|
A comparative study between intrathecally administered Fentanyl & Midazolam with Bupivacaine for prevention of nausea & vomiting undergoing infraumbilical surgeries. |
| 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 Chetan Shukla |
| Designation |
Senior Professor |
| Affiliation |
Principal Investigator (PI) |
| Address |
Department of Anaesthesia,Government Medical College, Rangbari, Kota, Rajasthan
Kota
RAJASTHAN
324005
India |
| Phone |
|
| Fax |
|
| Email |
chetanshukla_pallav@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetan Shukla |
| Designation |
Senior Professor |
| Affiliation |
Principal Investigator (PI) ( 89499 21637) |
| Address |
Department of Anaesthesia, Government Medical College, Rangbari, Kota, Rajasthan
Kota
RAJASTHAN
324005
India |
| Phone |
|
| Fax |
|
| Email |
chetanshukla_pallav@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Punia |
| Designation |
PG student |
| Affiliation |
Government Medical College, Kota |
| Address |
Department of Anesthesiology, Government Medical College, kota
Kota
RAJASTHAN
324001
India |
| Phone |
8107456268 |
| Fax |
|
| Email |
nidhipoonia123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Rangbari, Kota |
|
|
Primary Sponsor
|
| Name |
Government Medical College, Kota |
| Address |
Government Medical College, Rangbari, Kota Rajasthan |
| 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 |
| Dr Chetan Shukla |
Government Medical College and Hospital Kota |
Department of Anesthesiology,Government Medical College, Rangbari, Kota Rajasthan
Kota
RAJASTHAN |
8949921637
chetanshukla_pallav@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, Government Medical College,Kota |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Fentanyl and Inj. Midazolam |
0.25mL Fentanyl (12.5microgm) Intrathecally, once before surgery
0.25mL Midazolam (1.25mg) Intrathecally, once before surgery
Patients will be observed for 48 hours post op. |
| Comparator Agent |
Inj. Fentanyl(12.5microgm) and Inj. Midazolam(1.25mg) |
0.25mL Fentanyl (12.5microgm) Intrathecally, once before surgery
0.25mL Midazolam (1.25mg) Intrathecally, once before surgery
Patients will be observed for 48 hours post op. |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 and 2. Patients posted for infraumbilical surgeries. |
|
| ExclusionCriteria |
| Details |
Patients with hypertension, CAD, rental and hepatic disease. Patients with skin disease at the site of injection. Contraindication to regional anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare which amongst Fentanyl & Midazolam is better for prevention of nausea & vomiting undergoing infraumbilical surgeries. |
48 hours post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the vital parameters between the two groups & to study any side effects or complications & treat them with utmost care
|
48 hours post op |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/02/2024 |
| 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="3"
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
|
The most common and discomforting symptoms which follow
anaesthesia and surgery are emesis and pain. Sometimes nausea and vomiting may be so distressing especially after minor and ambulatory surgeries that it delays the hospital discharge.One of the key factors in this regard is visceral pain and pain resulting from traction of peritoneum. The present study is done to compare the effectiveness of adding fentanyl and midazolam with Bupivacaine in preventing the incidence of intra-operative and post-operative nausea and vomiting. |