CTRI/2024/12/078347 [Registered on: 19/12/2024] Trial Registered Prospectively
Last Modified On:
19/12/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Study comparing Dexmedetomidine, clonidine, and Pethidine to prevent shivering after spinal anesthesia in surgery
Scientific Title of Study
A randomised double blinded study of Dexmedetomidine, clonidine,pethidine for control of post spinal shivering in patients undergoing elective surgeries
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
SRI RANJANI B
Designation
POSTGRADUATE RESIDENT
Affiliation
Chettinad hospital and research institute
Address
D block , 1st floor,Department of Anaesthesiology,Chettinad hospital and research institute,chettinad health city,Rajiv Gandhi Salai( OMR) ,kelambakkam
Chennai TAMIL NADU 603103 India
Phone
9003070894
Fax
Email
ranjanisrivignesh@gmail.com
Details of Contact Person Scientific Query
Name
Dr ASHOK KULASEKHAR
Designation
Professor Head of the Department
Affiliation
Chettinad Hospital and research Institute
Address
Professor Head of the department, D- block 1st floor, Department of Anaesthesiology, chettinad Hospital and Research Institute, Chettinad Health city, Rajiv Gandhi salai, Kelambakkam
Chennai TAMIL NADU 603103 India
Phone
9840498420
Fax
Email
ashokk_dr@yahoo.com
Details of Contact Person Public Query
Name
Dr ASHOK KULASEKHAR
Designation
Professor Head of the Department
Affiliation
Chettinad Hospital and research Institute
Address
Professor Head of the department, D- block 1st floor, Department of Anaesthesiology, chettinad Hospital and Research Institute, Chettinad Health city, Rajiv Gandhi salai, Kelambakkam
Chennai TAMIL NADU 603103 India
Phone
9840498420
Fax
Email
ashokk_dr@yahoo.com
Source of Monetary or Material Support
Chettinad hospital and Research Institute, Chettinad Health city, Rajiv Gandhi salai, Kelambakkam, Chennai, Tamilnadu 603103
Primary Sponsor
Name
Chettinad hospital and research institute
Address
Chettinad hospital and research institute, chettinad health city, Rajiv Gandhi Salai,Kelambakkam, chennai, Tamilnadu, India-603103
Type of Sponsor
Private medical college
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr B SRI RANJANI
Chettinad hospital and research institute
D- block , 1st floor, Department of Anaesthesiology, Chettinad Health city, Chettinad health city,Rajiv Gandhi Salai,Kelambakkam,,Chennai,Tamilnadu ,India-603103 Chennai TAMIL NADU
9003070894
ranjansrivignesh@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
INSTITUTIONAL HUMAN ETHICS COMMITTEE ( CARE IHEC- I)
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: 4||Measurement and Monitoring,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Dexmedetomidine and clonidine
Dexmedetomidine 0.5 mcg/ kg intravenous dose and clonidine 1 mcg/kg intravenous dose will be given when shivering occurs after spinal anesthesia for 2 hrs
Comparator Agent
Pethidine
Pethidine 0.5mg/ kg intravenous dose when shivering occurs after spinal anesthesia for 2 hrs
Inclusion Criteria
Age From
20.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Inclusion criteria:
1)Patients aged 20-60 years
2)ASA -1,2
3)Shivering grade 2-3 ( Crossley and Mahajan scale)
4)Elective surgeries
ExclusionCriteria
Details
1) patient aged less than 20 yrs and more than 60 yrs
2)Fever, drug allergic reactions ,thyroid illness, neuromuscular diseases
3)Patients with cardiac disease( heart blocks,LVF) ,psychiatry illness
4)Patient who develop shivering even before giving spinal Anesthesia
ASA -3,4
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 compare the time taken to control shivering between Dexmedetomidine, clonidine , pethidine
120 mins
Secondary Outcome
Outcome
TimePoints
To assess sedation using Filos sedation scale
To assess other hemodynamic changes , adverse effects of these drugs
120 mins
Target Sample Size
Total Sample Size="90" Sample Size from India="90" Final Enrollment numbers achieved (Total)= "90" Final Enrollment numbers achieved (India)="90"
Phase of Trial
Phase 4
Date of First Enrollment (India)
01/01/2025
Date of Study Completion (India)
31/07/2024
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
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 a common complication of spinal anesthesia in 70 percent of patients undergoing surgery under spinal anesthesia .Shivering causes certain physiologic complications which includes increase in oxygen consumption, hypercarbia, increase in minute ventilation .It induces arterial hypoxemia , lactic acidosis, increased intraocular pressure,ICT,damage to dental prosthesis thereby interfering with patient monitoring.Various pharmacological and non pharmacological methods are control of shivering during spinal anesthesia . Pharmacological methods using various drugs include tramadol, clonidine , Dexmedetomidine,doxapram, pethidine, nefopam, neostigmine,magnesium sulphate, ketamine have been tried.Dexmedetomidine and clonidine is a selective alpha 2 adrenergic receptor agonist ,Dexmedetomidine is highly selective alpha 2 agonist with antihypertensive, sedative, analgesic properties along with antishivering properties
Pethidine is a mu opioid receptor agonist ,it has analgesic and anti shivering properties.In this study we compare the efficacy of Dexmedetomidine, pethidine , clonidine with respect to study time from drug administration to control of shivering,recurrence time .
AIM:
The aim of the study is to compare the control of post spinal shivering using Dexmedetomidine, clonidine , pethidine in patients undergoing elective surgeries
PRIMARY OBJECTIVE:
To compare the time taken to control shivering between Dexmedetomidine, clonidine using pethidine as control group
SECONDARY OBJECTIVE:
To assess sedation using Filos sedation scale
To assess other hemodynamic changes , adverse effects of these drugs over 120 mins
Study design: Prospective ,randomised, double blinded case study
Sample size
Cochran formula is
n=Z(square)pq/e(square)
Where:
Z is in general 1.96 at level of significance being 0.05
e is the desired level of precision (i.e. the margin of error),
p is the (estimated) proportion of the population which has the attribute in question,
q is 1 – p.
In the given proposal,
Z = 1.96
p = 0.22 (assumption based on the practical experience Ref : Halvadia et al 2020))
q = 0.78
e = 0.15 (assumption)
The sample size works out to 29.2986 which is approximately 30.
Hence the sample size suggested for the present study is 30 in each group.
Groups:
Group D - Dexmedetomidine group receiving single intravenous bolus dose of 0.5 mcg/ kg in 100 ml NS over 10 mins
Group P- Pethidine group patients receiving 0.5 mg/ kg Pethidine IV over 10 mins
Group C- clonidine group patients receiving 1 mcg/ kg clonidine IV in 100 ml NS over 10 mins
Inclusion criteria:
Patients aged 20-60 years
ASA -1,2
Shivering grade 2-3 ( Crossley and Mahajan scale)
Elective surgeries
Exclusion criteria:
Age <20 and > 60
Fever, drug allergic reactions ,thyroid illness, neuromuscular diseases
Patients with cardiac disease( heart blocks,LVF) ,psychiatry illness
Patient who develop shivering even before giving spinal Anesthesia
ASA -3,4
All patients were instructed to fast for 8 hrs for solid diet prior to surgery.All patients were pre medicated with Tablet ALPRAZOLAM 0.5 mg and Tablet PANTOPRAZOLE 40 mg orally on the night before surgery and morning of surgery. Informed and written consent will be obtained pre operatively.Patients baseline pre operative vitals will be recorded ( HR, BP, MAP, SPO2).The patient will be transferred to operating room.After entering OT room an intravenous (IV) line will be established with an 18 G IV catheter in the dorsum of hand or wrist vein.Standard monitoring with electrocardiography, non invasive blood pressure, pulse oximetry will be performed as per ASA guidelines.BP,HR, SPO2, Temperature will be measured at appropriate levels.Operation theatre temperature will be kept at 22-25 degree Celsius .Warmer, warming blankets, warm fluids will be kept.Under sterile aseptic precautions all patients will receive sub arachanoid block at L3-L4 or L4-L5, level with patients in sitting or lateral position using 25 or 26 G Quincke needle.After cerebrospinal fluid is detected Inj 0.5 Bupivacaine H will be injected along with Inj Buprenorphine counting on the need for surgery as per Anesthesiologist decision .Shivering of grade 2 and grade 3 as proposed by Crossley and Mahajan scale of shivering will be considered to need of treatment
When patient developed shivering they were allocated to 3 groups as computer generated random numbers as group D, C,P and the study drug was then administered intravenously as per assigned group .The time from drug administration until the disappearance of shivering will be noted accurately in second.Patients will be monitored at intervals of 1 min, 3 min, 5min, 10 mins, 20 mins, 30 mins until the End of surger. Crossley and Mahajan scale of shivering ( grade0 - no shivering, grade 1- mild fasciculation of face or neck,grade2- visible tremor involving more than one muscle group, grade-3 gross muscular activity involving the entire body).Patients will be monitored for drug failure, recurrence of shivering,side effects like Vomiting , hypotension.
Sedation score was evaluated with a four point scale as per filos I
References
Venkatraman R, Karthik K, Pushparani A, Mahalakshmi A. A prospective, randomized, double-blinded control study on comparison of tramadol, clonidine and dexmedetomidine for post spinal anesthesia shivering. Rev Bras Anestesiol. 2018;68:42–8. [PMCID: PMC9391672] [PubMed: 28546012]
Bajwa SJ, Gupta S, Kaur J, Singh A, Parmar S. Reduction in the incidence of shivering with perioperative dexmedetomidine: A randomized prospective study. J Anaesthesiol Clin Pharmacol. 2012;28:86–91. [PMCID: PMC3275980] [PubMed: 22345953]
Shukla U, Malhotra K, Prabhakar T. A comparative study of the effect of clonidine and tramadol on post-spinal anaesthesia shivering. Indian J Anaesth. 2011;55:242–6. [ PMCID: PMC3141147] [PubMed: 21808395]