| CTRI Number |
CTRI/2025/02/080993 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing 2 drugs for preventing spinal anaesthesia induced shivering in leg and lower abdominal surgeries |
|
Scientific Title of Study
|
Comparison of Effectiveness of Norepinephrine versus Phenylephrine Infusions in Preventing Post-Spinal Anaesthetic Shivering in Lower Limb and Lower Abdominal Surgeries: A Randomised 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 |
SURYANARAYANAN S |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology, MAPIMS, MELMARUVATHUR
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8754924600 |
| Fax |
|
| Email |
surya19692@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SURYANARAYANAN S |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology, MAPIMS, MELMARUVATHUR
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8754924600 |
| Fax |
|
| Email |
surya19692@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SURYANARAYANAN S |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology, MAPIMS, MELMARUVATHUR
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8754924600 |
| Fax |
|
| Email |
surya19692@gmail.com |
|
|
Source of Monetary or Material Support
|
| Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur, Kancheepuram District,Tamilnadu |
|
|
Primary Sponsor
|
| Name |
S. Suryanarayanan |
| Address |
No.14, Annai Therasa Street, Sivaji Nagar, Gorimedu, Puducherry -605006 |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| Suryanarayanan S |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
Operation theatre No. 4,5,6,9, Melmaruvathur
Kancheepuram
TAMIL NADU |
8754924600
surya19692@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAPIMS-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (3) ICD-10 Condition: N211||Calculus in urethra, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% Normal Saline |
0.9% Normal Saline will be used as placebo and will be administered to the 3rd group |
| Intervention |
Norepinephrine |
Norepinephrine infusion (5 mics/ml) will be administered for 1 group |
| Intervention |
Phenylephrine |
Phenylephrine infusion (50mics/ml) will be administered for 2nd group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients within the age group of 18 to 55 years posted for orthopaedic surgeries of lower limb or hip and lower abdominal surgeries belonging to ASA-PS category 1 or 2 |
|
| ExclusionCriteria |
| Details |
Refusal to consent
Patient with any contraindication for spinal anaesthesia
Allergy to Phenylephrine or Norepinephrine
Those patients requiring additional sedation or analgesia or general anaesthesia either due to inadequate sensory or motor block or due to unanticipated prolongation of the surgery.
Patients requiring blood transfusion
Postoperative Visual Analogue Score more than 5
In any patient to whom preoperative anxiolytic medication is not administered
Obesity (BMI more than 35kg/m2)
Those suffering from severe vital organ dysfunction (such as heart, brain, liver and kidney).
Fever (axillary temperature more than 37 degree celcius)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of post spinal anesthetic shivering. |
2, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120 and 180 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the severity of shivering using Bedside Shivering Assessment Score. |
2, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120 and 180 minutes |
| To evaluate the hemodynamic changes with study drugs |
2, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120 and 180 minutes |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
24/02/2025 |
| 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
|
Post-spinal shivering is a frequent complication following spinal
anesthesia, affecting 40-60% of patients. While the precise mechanisms behind
post-spinal shivering remain unclear, it is primarily attributed to
thermoregulatory disturbances caused by sympathetic blockade and the
redistribution of body heat. Additional contributing factors may include pain,
disinhibited spinal reflexes, decreased sympathetic activity, and respiratory
alkalosis. Various pharmacological agents (meperidine, tramadol, paracetamol,
dexamethasone, clonidine, dexmedetomidine, and phenylephrine) and
non-pharmacological measures (body blankets, fluid warmers and forced air
warmer) have been explored for prevention and management of post spinal shivering. However, most studies focus
on symptom management rather than addressing the root cause of shivering, which
is often hypothermia, with phenylephrine being one of the few agents studied in
this regard. Previous
studies have primarily compared between boluses of phenylephrine and
norepinephrine for treating hypotension. Few studies have used
phenylephrine infusion for prevention of hypotension and thereby post spinal
shivering. The aim of this research is to compare the effectiveness of
prophylactic norepinephrine versus phenylephrine infusions with control drug
(normal saline) at a fixed rate to minimize hemodynamic fluctuations, maintain
normothermia, and consequently reduce the incidence of post-spinal anesthetic shivering
in lower limb and lower abdominal surgeries. We hypothesize that norepinephrine
will be more effective than phenylephrine in reducing post spinal anesthetic
shivering. |