| CTRI Number |
CTRI/2024/05/066879 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/04/2024 |
| 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 phenylephrine infusion on shivering after spinal anaesthesia in caesarean section deliveries |
|
Scientific Title of Study
|
Low dose phenylephrine infusion for post spinal shivering in elective caesarean deliveries: A randomized 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 |
Renuka |
| Designation |
Junior Resident |
| Affiliation |
Karnataka institute of medical sciences hubballi |
| Address |
Department of Anesthesiology, Karnataka Institute of Medical Sciences, Hubli Karnataka India
Dharwad
KARNATAKA
580021 India
Dharwad
KARNATAKA
580021
India |
| Phone |
9148686925 |
| Fax |
|
| Email |
1997kulkarnirenuka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa S |
| Designation |
Associate professor |
| Affiliation |
Karnataka institute of medical sciences hubballi |
| Address |
Department of Anesthesiology, Karnataka Institute of Medical Sciences, Hubli Karnataka
Dharwad
KARNATAKA
580021 India
Dharwad
KARNATAKA
580021
India |
| Phone |
9448658220 |
| Fax |
|
| Email |
roopasac@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa S |
| Designation |
Associate professor |
| Affiliation |
Karnataka institute of medical sciences hubballi |
| Address |
Department of Anesthesiology, Karnataka Institute of Medical Sciences, Hubli Karnataka
Dharwad
KARNATAKA
580021 India
Dharwad
KARNATAKA
580021
India |
| Phone |
9448658220 |
| Fax |
|
| Email |
roopasac@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Sciences
Hubballi |
|
|
Primary Sponsor
|
| Name |
Karnataka Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Karnataka Institute of Medical Sciences, Vidyanagar, Hubli Karnataka 580021 |
| 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 |
| Renuka |
Karnataka Institute of Medical Science |
Department of Anesthesiology Karnataka Institute of Medical Sciences, Vidyanagar, Hubli Karnataka 580021 Dharwad KARNATAKA
Dharwad
KARNATAKA |
9148686925
1997kulkarnirenuka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Karnataka Institute of Medical Sciences, Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O898||Other complications of anesthesiaduring the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LOW DOSE PHENYLEPHRINE INFUSION INTRAOPERATIVELY |
Dose- 25µg/min phenylephrine infusion after spinal anaesthesia intraoperatively
Duration of surgery-120min |
| Comparator Agent |
NORMAL SALINE INFUSION |
Normal saline infusion intraoperatively
Duration of surgery -120min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women aged between 18 to 40 years, belonging to ASA-PS II undergoing elective caesarean section under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Preoperative hyperthermia (more than 38 degree Celsius) or hypothermia ( less than 36 degree Celsius)
2. BMI more than 30 kg per metre square
3. Patients with history of bradycardia, severe cardiac dysfunction, heart failure, pulmonary arterial hypertension
4. Patients with ear disease
5. Surgical time more 2 hours
6. Intraoperative blood transfusion
7. Patients with diabetes mellitus, pregnancy induced hypertension, hypothyroid or hyperthyroid, anemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased incidence of shivering after spinal anaesthesia intraoperatively |
-Preoperatively
-Immediately after spinal anaesthesia
-Every 10 min till 120 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Decreased change in core body temperature intraoperatively and postoperatively
2. Decreased incidence of hypotension intraoperatively, nausea and vomiting postoperatively |
1. Shivering upto 120 min
2. Nausea and vomiting upto 24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/05/2024 |
| 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="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
|
Shivering after spinal anaesthesia is a common complication. This leads to redistribution of central heat to the periphery and overall heat loss. Shivering increases oxygen consumption, metabolic rate, carbon dioxide production, lactic acidosis. Also it interferes with electrocardiography, blood pressure, oxygen saturation monitoring and has its detrimental effects on wound healing and coagulation. Phenylephrine being a alpha-1 adrenergic receptor agonist, due to its peripheral vasoconstrictive effect, the core to peripheral redistribution of blood volume is minimal, which may maintainthe core body temperature and reduce shivering during spinal andestnesia. Aim: Low dose phenylephrine infusion after spinal anesthesia may decrease incidence of shivering in caesarean sections.
Objectives: 1.To evaluate the effect of phenylephrine infusion on incidence of shivering. 2.To evaluate the effect of phenylephrine infusion on - Severity of shivering.
- Intraoperative core body temperature.
- Intraoperative hypotension.
Materials and methods: A prospective randomized controlled trial
Sample size: 45 in each group
|