Comparison Between IT Fentanyl and IV Granisetron in Prevention of Vomiting in CS Under Spinal Anesthesia

April 17, 2023 updated by: Mohamed Youssef Mohamed

Intrathecal Fentanyl Versus Intravenous Granisetron for the Prevention of Perioperative Nausea and Vomiting During Cesarean Delivery Under Spinal Anesthesia

Intrathecal Fentanyl Versus Intravenous Granisetron for the Prevention of Perioperative Nausea and Vomiting During Cesarean Delivery under Spinal Anesthesia

Study Overview

Detailed Description

This prospective randomized control study will be held in Sohag University Hospital After approval of local ethics committee of sohag university hospital from June 2022 to December 2022, written informed consent will be taken from all patients , about advantages and possible complications of this study .

Inclusion criteria This study will include 90 Patients , physical status I or II according to ASA classification , age between ( 18 - 45 years ) undergoing cesarean delivery under spinal anesthesia.

Technique :

On arrival of patient to operative room :

  1. 20G IV line ( cannula ) will be inserted .
  2. Putting of patient on monitor and assessment of hemodynamics ( HR , RR , BP ) .
  3. Pre anesthetic hydration by at least 1000 ml ringer lactate
  4. Patient received Spinal anesthesia at level L3-L4 or L4-L5 lumbar segement .
  5. during the procedure, If patient suffer from :

    • brady cardia with heart rate ( HR ) less than 55 we will give atropine sulphate 0.5 mg IV .
    • hypotension less than 25% of MBP of preoperative value we will give normal saline or ephedrine 5-10 mg .
  6. Putting patient in the position for the operation .

Patients will be prospectively randomized divided into 3 groups :

The patients will be randomized using closed envelope method and the medications will be prepared by another anaesthologist not sharing in the study

Group ( F ) Fentanyl group : ( n = 30 ) Patients will receive 10 mg hyperbaric Bupivacaine ( 2ml ) and 20 μg (0.5 mL) fentanyl IT.

1 mL IV normal saline immediately after the placement of the spinal. Group ( G ) Granisetron group : ( n = 30 ) Patients will receive 10 mg hyperbaric Bupivacaine ( 2ml ) and 0.5 mL normal saline IT.

1 mg (1 mL) IV granisetron after spinal placement. Group ( C ) Control group : ( n = 30 ) 10 mg hyperbaric Bupivacaine ( 2ml ) IT and normal saline 0.5 ml

1 ml normal saline IV after spinal placement.

\Data will be collected from this study : ( 1 ) : Demographic data : Age , sex , weight , height and duration of operation .

( 2 ) : intraoperative:

A- hemodynamics (HR , BP , RR , oxygen saturation before anesthesia , after induction and then :

Every 5 minutes for 1st hour Every 15 minutes for next 2 hours Then every 3 hour for 12 h post operative . B - nausea and vomiting. C - patient discomfort during anesthesia. D - itching. ( 3 ) : post operative : A - nausea and vomiting : using nausea and vomiting score. B - pain assessment using VAS : every 30 mins for 2 h , every hour for 12 h If VAS 3-5 we will give paracetamol 1g IV , more than 5 we will give ketrolac 30 mg IV C _ total analgesic consumption D _ itching F _ retention of urine

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • physical status I or II according to ASA classification with age between ( 18 - 45 years ) undergoing cesarean delivery under spinal anesthesia.

Exclusion Criteria:

  • patient refusal .
  • Any contraindication of neuraxial block.
  • Patients with physical status other than 1 and 2 according to ASA classification
  • Those with history of nausea and vomiting as Parturients with a history of motion sickness, hyperemesis gravidarum , also those who received anti emetic drugs in last 2 hours of operation .
  • Allergy to any of the drug included in this study .
  • complicated pregnancy as placenta previa, preeclampsia and eclampsia multible pregnancy
  • fetal distress

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fentanyl group

Patients will receive 10 mg hyperbaric Bupivacaine ( 2ml ) and 20 μg (0.5 mL) fentanyl IT.

1 mL IV normal saline immediately after the placement of the spinal.

10mg bubivacain intrathecal ( 2ml ) with 20microgram intrathecal fentanyl
Other Names:
  • IT Fentanyl
Active Comparator: Granisetron group

Patients will receive 10 mg hyperbaric Bupivacaine ( 2ml ) and 0.5 mL normal saline IT.

1 mg (1 mL) IV granisetron after spinal placement.

10mg bubivacain intrathecal ( 2ml ) with 0.5 ml saline with no intrathecal fentanyl with 1mg iv granisetron
Other Names:
  • IV Grantryl
Placebo Comparator: Control group

10 mg hyperbaric Bupivacaine ( 2ml ) IT and normal saline 0.5 ml

1 ml normal saline IV after spinal placement.

10mg bubivacain intrathecal (2ml) with 0.5 ml saline with no intrathecal fentanyl
Other Names:
  • IT mercaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nausea and vomiting score in patient during caesarean delivery
Time Frame: six month

: To compare intrathecal (IT) fentanyl with IV granisetron for preventing intraoperative nausea and vomiting during cesarean deliveries performed with spinal anesthesia.

according to nausea and vomiting scale ( from 0 = no nausea , to 10= resistant nausea and vomiting )

six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

January 30, 2024

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

July 23, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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