| CTRI Number |
CTRI/2023/07/055153 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effect of low dose Phenylephrine infusion for prevention of shivering in patients undergoing elective lower segment Cesarean section - A Prospective Randomized Double Blinded Controlled Study |
|
Scientific Title of Study
|
Efficacy of low dose Phenylephrine infusion for prevention of shivering in patients undergoing elective lower segment Cesarean section - A Prospective Randomized Double Blinded Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abi vignesh prabu G |
| Designation |
Second year post graduate resident M.D.Anesthesiology |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Room No : A6, Anesthesia Department ,Sri Ramachandra Institute Of Higher Education And Research, Ramachandra Nagar, Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9363005247 |
| Fax |
|
| Email |
abivignesh.19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akilandeshwari |
| Designation |
Professor M.D.Anaesthesiology |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Room No : A6, Anesthesia Department, Sri Ramachandra Institute Of Higher Education And Research, Ramachandra Nagar, Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840636238 |
| Fax |
|
| Email |
akilaanes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akilandeshwari |
| Designation |
PROFESSOR M.D.ANAESTHESIOLOGY |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Room No : A6, Anesthesia Department, Sri Ramachandra Institute Of Higher Education And Research, Ramachandra Nagar,
Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840636238 |
| Fax |
|
| Email |
akilaanes@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, PORUR, CHENNAI-600116 |
|
|
Primary Sponsor
|
| Name |
Abi vignesh prabu G |
| Address |
Room No : A6, Anesthesia Department ,Sri Ramachandra Institute Of Higher Education And Research, Ramachandra Nagar, Porur, Chennai-600116 |
| Type of Sponsor |
Other [Self financing] |
|
|
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 |
| Abi vignesh prabu G |
Sri Ramachandra Institute Of Higher Education And Research |
Department of Anesthesia, Operating rooms division, Room Number A6
Chennai
TAMIL NADU |
9363005247
abivignesh.19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra Institute Of Higher Education And Research, Porur, Chennai - 600116 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low dose Phenylephrine infusion in prevention of shivering in elective lower segment cesarean section |
Low dose of Phenylephrine infusion is given
at a rate of 0.25mcgs/kg/min is given immediately after spinal
anaesthesia through intravenous route at continuous frequency till the end of the procedure to assess its efficacy in prevention of shivering |
| Comparator Agent |
Normal saline infusion as same rate of Phenylephrine infusion |
Participants receiving normal saline infusion at 15ml per hour dose through intravenous route at continuous frequency till the end of the entire procedure will receive conventional treatment for shivering such as Injection TRAMADOL 50mg, through intravenous route, at required frequency, till the end of the procedure |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients undergoing elective lower segment caesarean section
2. ASA class II
3. Age >18 years
|
|
| ExclusionCriteria |
| Details |
1. Patients with fever >37 degree Celsius
2. Hypertensive disorders
3. Cardiac diseases
4. Antepartum hemorrhage
5. Known allergy to drugs used in study
6. Intraoperative blood loss more than 1000ml
7. Need for RBC transfusion
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Incidence of shivering
2)Grade of shivering
3)Need for rescue medications
|
1)Incidence of shivering is assessed from 1 minute after giving spinal anesthesia till the entire cesarean section and estimated at baseline
2)Grade of shivering is assessed from 1 minute after giving spinal anesthesia till the entire Cesarean section estimated at baseline
3)Need for rescue medications is assessed from 1 minute after giving spinal anesthesia till the end of Cesarean section
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Temperature
2)Mean arterial pressure
3)Systolic & diastolic pressure
|
1)Temperature at baseline & 1 minute after giving spinal anesthesia till the end of procedure & in Post Anesthetic care unit
2)Mean arterial pressure at baseline & 1 minute after giving spinal anesthesia till the end of procedure & in Post Anesthetic care unit
3)Systolic & diastolic pressure at baseline & 1 minute after giving spinal anesthesia till the end of procedure & in Post Anesthetic care unit
|
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "112"
Final Enrollment numbers achieved (India)="112" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/07/2023 |
| Date of Study Completion (India) |
01/03/2024 |
| Date of First Enrollment (Global) |
22/07/2023 |
| Date of Study Completion (Global) |
01/03/2024 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Shivering is the most common complication seen in patients undergoing cesarean section under spinal anesthesia. So far prophylactic treatment has not yet been given routinely for prevention of shivering after giving spinal anesthesia in patients undergoing cesarean section. Studies has shown that fixed doses of Phenylephrine can prevent shivering. Based on the studies , we designed a study assuming low dose of Phenylephrine infusion of 0.25 micrograms per kilograms per minute infusions can prevent shivering and hypotension |