CTRI

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CTRI Number

CTRI/2021/09/036325 [Registered on: 08/09/2021] Trial Registered Prospectively

Last Modified On:

07/09/2021

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparison of Premixed vs Sequential Administration of Fentanyl as an Adjuvant to Low dose Intrathecal Hyperbaric Bupivacaine in Lower Segment Cesarean Section

Scientific Title of Study

Comparison of Premixed vs Sequential Administration of Fentanyl as an Adjuvant to Low dose Intrathecal Hyperbaric Bupivacaine in Lower Segment Cesarean Section

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Ashay Jain
Designation	Resident Doctor
Affiliation	Teerthanker Mahaveer Medical College and Research centre, Moradabad U.P.
Address	Department of Anesthesia Teerthanker Mahaveer Medical College and Research centre, Moradabad U.P. Moradabad UTTAR PRADESH 244001 India
Phone	8770995726
Fax
Email	aashayjain142@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Rohit Kumar Varshney
Designation	Professor
Affiliation	Teerthanker Mahaveer Medical College and Research centre, Moradabad U.P.
Address	Department of Anesthesia Teerthanker Mahaveer Medical College and Research centre, Moradabad U.P. Moradabad UTTAR PRADESH 244001 India
Phone	9897490444
Fax
Email	rohitmaxy@gmail.com

Details of Contact Person
Public Query

Name	Dr Ashay Jain
Designation	Resident Doctor
Affiliation	Teerthanker Mahaveer Medical College and Research centre, Moradabad U.P.
Address	Department of Anesthesia Teerthanker Mahaveer Medical College and Research centre, Moradabad U.P. Moradabad UTTAR PRADESH 244001 India
Phone	8770995726
Fax
Email	aashayjain142@gmail.com

Source of Monetary or Material Support

Teerthanker mahaveer medical College and research centre, Moradabad U.P.

Primary Sponsor

Name	Teerthanker Mahaveer Medical College and Research centre Moradabad UP
Address	Department of Anesthesia Teerthanker Mahaveer Medical College and Research centre, Moradabad U.P.
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
Ashay Jain	Teerthanker Mahaveer Medical College	Department of Anesthesia Teerthanker Mahaveer Medical College and Research Centre, Moradabad U.P. Moradabad UTTAR PRADESH	8770995726 aashayjain142@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O295\|\|Other complications of spinal andepidural anesthesia during pregnancy,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Fentanyl	Fentanyl to be given in Premixed with Bupivacaine in one group and sequentially in other group
Intervention	Spinal anaesthesia	Premixed vs sequential fentanyl as adjuvant to low dose hyperbaric bupivacaine.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Female
Details	1.American Society of Anaesthesiologists (ASA) physical status I or II undergoing Lower Segment Cesarean Section. 2.Patient between the age group of 18-40 years.

ExclusionCriteria

Details

1.Patient with contraindication for spinal anaesthesia.
2.Height less than 150 cms.
3.Patient having severe pregnancy induced hypertension (PIH), intrauterine deaths or unknown fetal anomaly.
4.Patients allergic to any medications.
5.Patient not giving consent for study.
6.Patients with associated liver/renal/cardiac/pulmonary disease

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Case Record Numbers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
1.To compare the hemodynamic parameters between premixed and sequential group. 2.To compare the onset and duration of sensory block between both group. 3.To compare the onset and duration of motor block between both group.	Hemodynamic parameters at 5,10,15,20,25,30,40,50,60,70,80 minutes

Secondary Outcome

Outcome	TimePoints
1. To record APGAR score at 1 min and 5 min respectively 2. To record any complications if any	APGAR score at 1min and 5 min

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

N/A

Date of First Enrollment (India)

10/09/2021

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

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Hyperbaric Bupivacaine is the most commonly used local anesthetic for spinal anesthesia.

As it is heavier than CSF, it generally settles down. Giving low dose of Hyperbaric Bupivacaine will reduce the incidence of Hypotension. and combining it with Fentanyl, which is an opioid will prolong the effect and duration of anesthesia and will provide better analgesia. Also, it will be good for the Parturients as low dose of bupivacaine is used (7.5mg)