CTRI

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CTRI Number

CTRI/2025/02/081439 [Registered on: 28/02/2025] Trial Registered Prospectively

Last Modified On:

12/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Prophylactic fixed rate phenylephrine versus norepinephrine infusion for the prevention post spinal hypotension during lower abdominal surgery

Scientific Title of Study

Prophylactic fixed-rate phenylephrine versus norepinephrine infusion for the prevention of post-spinal anesthesia hypotension during lower abdomen surgeries a prospective double blinded randomised controlled trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	SYED FAZIL A
Designation	JUNIOR RESIDENT
Affiliation	ALL INDIA INSTITUTE OF MEDICAL SCIENCE GORAKHPUR
Address	Department of anesthesiology All India Institute of Medical Sciences Gorakhpur Uttar Pradesh India Gorakhpur UTTAR PRADESH 273008 India
Phone	8667661562
Fax
Email	sfazil02@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Vikram vardhan
Designation	Head of Department of Anesthesiology
Affiliation	ALL INDIA INSTITUTE OF MEDICAL SCIENCE GORAKHPUR
Address	Department of anesthesiology All India Institute of Medical Sciences Gorakhpur Uttar Pradesh India Kunraghat, Gorakhpur, Uttar Pradesh 273008 Gorakhpur UTTAR PRADESH 273008 India
Phone	93232 67123
Fax
Email	vikram15vardhan@gmail.com

Details of Contact Person
Public Query

Name	Dr Vikram vardhan
Designation	Head of Department of Anesthesiology
Affiliation	ALL INDIA INSTITUTE OF MEDICAL SCIENCE GORAKHPUR
Address	Department of anesthesiology ALL India Institute of Medical Sciences Gorakhpur Uttar Pradesh Kunraghat, Gorakhpur, Uttar Pradesh 273008 Gorakhpur UTTAR PRADESH 273008 India
Phone	9323267123
Fax
Email	vikram15vardhan@gmail.com

Source of Monetary or Material Support

All India Institute of Medical Sciences Gorakhpur Uttar Pradesh India 273008

Primary Sponsor

Name	Dr SYED FAZIL A
Address	All India Institute of Medical Sciences Gorakhpur Uttar Pradesh India 273008
Type of Sponsor	Other [Self]

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 SYED FAZIL A	All India Institute of Medical Sciences Gorakhpur	Department of Anesthesiology OT complex All India Institute of Medical Sciences Gorakhpur Uttar Pradesh 273008 Gorakhpur UTTAR PRADESH	8667661562 sfazil02@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Human Ethics Committee All India Institute of Medical Sciences Gorakhpur Uttar Pradesh pincode 273008	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Prophylatic pre fixed Noradrenaline in prevention of post spinal hypotension	Pre-anaesthetic check-up of each patient will be done with detailed history, complete physical examination and relevant laboratory investigations including coagulation profile as per the standard pre anaesthetic check-up protocol. All patients will be advised for 6 hours fasting before surgery as per the latest ASA fasting guidelines. All patients will be explained about the procedure, advantage and associated risk of intervention and written informed consent will be obtained. Patient shifted to OT - IV access Preloading with 10 ml/kg of Ringer lactate done in all patient. The study drug will be given 10 minutes before spinal anaesthesia. Establishing minimum standard monitoring - ECG, Non-invasive blood pressure - NIBP, Oxygen saturation - SpO2 Mephentermine 6 mg will be used as a rescue drug, for the patients having hypotension (20% less than the baseline systolic pressure or MAP less than 65 mm Hg) Spinal anaesthesia will be given with 25G Quincke’s needle at L4-L5 intervertebral levels with 3 ml of heavy hyperbaric plane bupivacaine 0.5% Sensory loss above T6 will be excluded from study Injection noradrenaline infusion (0.04microgram/kg/min) will be started 10 minutes before spinal and continued until the completion of surgery Blood pressure Heart rate Means arterial pressure Saturation Will be noted for every 3 minutes for first 30 minutes and then 5 minutes until completion of surgery
Comparator Agent	Prophylatic pre fixed Phenylephrine infusion in prevention of post spinal problem hypotension	Pre-anaesthetic check-up of each patient will be done with detailed history, complete physical examination and relevant laboratory investigations including coagulation profile as per the standard pre anaesthetic check-up protocol. All patients will be advised for 6 hours fasting before surgery as per the latest ASA fasting guidelines. All patients will be explained about the procedure, advantage and associated risk of intervention and written informed consent will be obtained. Patient shifted to OT - IV access Preloading with 10 ml/kg of Ringer lactate done in all patient. The study drug will be given 10 minutes before spinal anaesthesia. Establishing minimum standard monitoring - ECG, Non-invasive blood pressure - NIBP, Oxygen saturation - SpO2 Mephentermine 6 mg will be used as a rescue drug, for the patients having hypotension (20% less than the baseline systolic pressure or MAP less than 65 mm Hg) Spinal anaesthesia will be given with 25G Quincke’s needle at L4-L5 intervertebral levels with 3 ml of heavy hyperbaric plane bupivacaine 0.5% Sensory loss above T6 will be excluded from study Injection phenylephrine infusion (0.8microgram/kg/min) will be started 10 minutes before spinal and continued until the completion of surgery Blood pressure Heart rate Means arterial pressure Saturation Will be noted for every 3 minutes for first 30 minutes and then 5 minutes until completion of surgery

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	ASA 1 and 2 patients

ExclusionCriteria

Details

Patient’s refusal
Infection at the site
Coagulation abnormalities
Allergy to the study drug(s)
Repeat spinal or failed spinal
Pregnant females
Known case of hypertension
Heart rate increased or decreased 20% from baseline
Cardio Vascular diseases

Sensory loss above T6 level

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 efficacy and safety profile of pre emptive phenylephrine vs noradrenalinefor prevention of hypotension during spinal anesthesia in lower abdominal surgery	Prophylatic infusion is given 10 min prior to spinal and monitoring ( BP, Saturation,heart rate and mean arterial pressure)is done for every 3 min for first 30 min and then every 5 min until completion of surgery

Secondary Outcome

Outcome	TimePoints
To study hemodynamic stability between both drugs Use of mephentermine (rescue bolus) requirement Side effects & complications if any between both groups	Patient will be monitored for 2 hours after surgery for any complications & vitals monitoring

Target Sample Size

Total Sample Size="180"
Sample Size from India="180"
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

Phase 4

Date of First Enrollment (India)

15/03/2025

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="2"
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

Nowadays spinal anesthesia is widely used for elective lower abdominal surgeries. It is frequently accompanied by hypotension, which may be defined in absolute terms as a systolic blood pressure (SBP) less than 90 or 100 mmHg or in relative terms as a percentage (20% fall from baseline).[1] The severity of this hypotension depends on the height of the block, the position of the patient, and the volume status of them.But the chance of most serious complication such as postspinal hypotension is a major limitation of this technique.The incidence of hypotension can be as high as 70%–80% when pharmacological prophylaxis is not used.

Hypotension following spinal anesthesia is common and can be actively countered by the use of vasopressors. Prophylactic infusion of vasopressors with a rescue bolus dosing was observed to be more effective for hemodynamic stability when compared to administering a bolus dose alone. In this study, we plan to :

1. Compare prophylactic fixed-rate intravenous infusions of phenylephrine and norepinephrine during lower abdominal surgeries under spinal anesthesia

2. Compare the requirement of intraoperative provider-administered rescue bolus of mephentermine needed to overcome post-spinal anesthesia hypotension.

This study will conducted at the department of anesthesiology All India Institute of medical sciences Gorakhpur Uttar Pradesh India.This tertiary care hospital is equipped with advanced medical facilities and high volume of surgery cases.The setting ensures diverse access to patient population undergoing elective lower abdominal surgery.This study is a randomised,controlled, double blinded, parallel assignment, single centre designed to compare the efficacy of fixed rate prophylatic phenylephrine vs noradrenaline in prevention of post spinal hypotension in lower abdominal surgery.Inclusion and exclusion criterias will be followed.Randomisation will be computor based and with total sample size of 180 patients.