| CTRI Number |
CTRI/2024/09/073996 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study effect of Intravenous Magnesium Sulphate administration on Postoperative Analgesia
in infraumbilical surgeries under spinal anaesthesia. |
|
Scientific Title of Study
|
Effects of intravenous magnesium suphate administration on postoperative analgesia in infraumbilical surgeries under spinal anaesthesia |
| 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 Subhashree Jena |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr D.Y. Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Reseach Centre, Sant Tukaram Nagar, Pimpri, Pune
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Reseach Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9348212504 |
| Fax |
|
| Email |
sjena.128.sj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahbaz Hasnain |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
DR D.Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Reseach Centre, Sant Tukaram Nagar, Pimpri, Pune
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Reseach Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9764621253 |
| Fax |
|
| Email |
shahbazhsnn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahbaz Hasnain |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
DR D.Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Reseach Centre, Sant Tukaram Nagar, Pimpri, Pune
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Reseach Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9764621253 |
| Fax |
|
| Email |
shahbazhsnn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy, 5th Floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Reseach Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India Pincode-411018 |
|
|
Primary Sponsor
|
| Name |
Subhashree Jena |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Reseach Centre, Sant Tukaram Nagar, Pimpri, Pune |
| 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 Subhashree Jena |
Dr. D.Y. Patil Hospital and Research Centre |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Reseach Centre, Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA |
9348212504
sjena.128.sj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium Sulphate |
In the study group 0.5ml (250mg) of Inj. Magnesium Sulphate IV was given, followed by 500mg (25mg/ml) infusion was given at 20ml/hr for 1hour through intravenous route. In the control group 0.5ml NS will be given IV followed by infusion at 20ml/hr. |
| Comparator Agent |
Normal saline |
same volume of normal saline as bolus and infusion was given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-65years, undergoing lower abdominal surgeries
BMI 20-35 kg/m2
ASA Grade I and II
Mallampati Score Class I and II
Patients giving consent to be part of the study
Hemodynamically Stable Patients
Routine Investigations (CBC, RFT, LFT, SE)- within normal limits
Duration of Surgery less than 4 hours
|
|
| ExclusionCriteria |
| Details |
Patients unwilling to Consent
Patients with ASA Grade III or IV
Hemodynamical Instability (Hypotension, Bradycardia)
Severe or Uncontrolled Diabetes or Hypertension, CVD
Cardiovasular Disease (CAD, HF, Cardiomyopathies, Valvular Heart Diseases)
Hepatic Impairment, Renal Impairment
Known case of Coagulopathies, abnormal hemoglobin, Anaemia
Known case of Kyphoscoliosis and deformity of spine
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study effect of Intravenous Magnesium Sulphate administration on postoperative ananlgesia in infraumbilical surgeries under spinal anaesthesia |
After administration of the spinal anaesthesia, comparison between the two groups of onset and duration of sensory and motor blockade, duration of analgesia and time of rescue of analgesia will be assessed at baseline, after injection of study drug at immediate postop, 15mins, 30mins, 45mins, 60minms, 4hrs, 8hrs, 12hrs, 16hrs, 20hrs, 24hrs and assessment VAS score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study effect of Intravenous Magnesium Sulphate administration on postoperative ananlgesia in infraumbilical surgeries under spinal anaesthesia |
Duration of analgesia will be assessed post surgery after administration of magnesium sulphate & time of rescue analgesia will be assessed |
|
|
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)
|
24/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/09/2024 |
| 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 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
|
It is randomized and double blinded prospective study to evaluate the postoperative analgesic effect of Magnesium sulphate by perioperative administration via intravenous route and Intra-operative assessment of HR, BP, Spo2, RR, Input-Output was done. Postoperatively, the patients were assessed using VAS every 4 hours for 24hours. The Heart rate, Blood Pressure and MAP, Respiratory rate and SpO2 were also assessed every 4 hours for 24 hours. The secondary endpoints included assessment of the requirement of rescue analgesia and assessment of hemodynamic effects of magnesium administration in infraumbilical surgeries under spinal anaesthesia |