| CTRI Number |
CTRI/2022/05/042826 [Registered on: 26/05/2022] Trial Registered Prospectively |
| Last Modified On: |
24/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study pain relieving effects of magnesium sulphate when used along with fentanyl during hysteroscopy. |
|
Scientific Title of Study
|
A prospective randomized controlled study of analgesic effects of Magnesium Sulphate as an adjuvant to Fentanyl for monitored anaesthesia care during Hysteroscopy at SMS Medical College, Jaipur during 2021-2023. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shobha Purohit |
| Designation |
SENIOR PROFFESOR |
| Affiliation |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College and Attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7737050823 |
| Fax |
|
| Email |
purohit.shobha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha Purohit |
| Designation |
SENIOR PROFFESOR |
| Affiliation |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College and Attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7737050823 |
| Fax |
|
| Email |
purohit.shobha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Mishra |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College And Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College and Attached Hospitals, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7728857069 |
| Fax |
|
| Email |
mishrasonal1703@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sawai Man Singh Medical College and Attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Sawai Man Singh Medical College And Attached Hospitals |
| Address |
JLN Marg , Adarsh Nagar, Jaipur, Rajasthan
PIN Code: 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 |
| Dr Sonal Mishra |
Sawai Man Singh Medical College and Attached Hospitals |
Department of Anaesthesiology,2nd floor, Dhanwantari Building,Sawai Man Singh Medical College And Attached Hospitals,JLN Marg Adarsh Nagar, Jaipur, rajasthan
Jaipur
RAJASTHAN |
7728857069
mishrasonal1703@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.M.S Medical College And Attached Hospitals, Jaipurt |
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 |
| Comparator Agent |
injection 0.9% isotonic normal saline |
intravenous injectin 0.9% isotonic normal saline (100 ml) over 15 minutes prior to general anaesthesia |
| Intervention |
Injection Magnesium Sulphate |
Intravenous Magnesium Sulphate 50%(50 mg/kg) in 100 ml of 0.9% isotonic normal saline over 15 minutes prior to general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients undergoing hysteroscopy who are willing to give written and informed consent.
2. ASA Grade I and II.
3. Females of Age Group 18-55 years. |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of drug allergy
2.Patients with pre-existing Renal or Hepatic dysfunction
3. Patients with cardiovascular disease, hypertension, ejection fraction <40%, atrioventricular conductance disturbance.
4. Patients with a neurological disorder
5. Patients facing serious intraoperative hypoxemia and need endotracheal intubation.
6. Patients with a history of chronic pain.
7. BMI >30 kg/m2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in the proportion of cases needing rescue analgesia between the groups (using VNRS: more than 4 scores) within 4hrs postoperative. |
4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the difference in the mean dose of rescue analgesia between the groups.
2. To determine the difference in the proportion of cases with side effects throughout the procedure between the groups.
3. To compare the hemodynamic variables (HR, SBP, DBP, MAP, SpO2).
|
4 hours |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
31/05/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
By studying the effectiveness of Magnesium Sulphate in decreasing pain and use of opioids during hysteroscopies, will help in avoiding side effects related to opioid use and help in better postoperative management of pain. This can also open up to more research projects. |