NCT05474001

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

June 24, 2022

Last Update Submit

April 17, 2023

Conditions

Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

  • nausea and vomiting score in patient during caesarean delivery

    : 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

Study Arms (3)

Fentanyl group

ACTIVE COMPARATOR

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.

Drug: Fentanyl

Granisetron group

ACTIVE COMPARATOR

Patients will receive 10 mg hyperbaric Bupivacaine ( 2ml ) and 0.5 mL normal saline IT. 1 mg (1 mL) IV granisetron after spinal placement.

Drug: intravenous graniseton

Control group

PLACEBO COMPARATOR

10 mg hyperbaric Bupivacaine ( 2ml ) IT and normal saline 0.5 ml 1 ml normal saline IV after spinal placement.

Drug: Bupivacain

Interventions

FentanylDRUG

10mg bubivacain intrathecal ( 2ml ) with 20microgram intrathecal fentanyl

Also known as: IT Fentanyl
Fentanyl group
BupivacainDRUG

10mg bubivacain intrathecal (2ml) with 0.5 ml saline with no intrathecal fentanyl

Also known as: IT mercaine
Control group
intravenous granisetonDRUG

10mg bubivacain intrathecal ( 2ml ) with 0.5 ml saline with no intrathecal fentanyl with 1mg iv granisetron

Also known as: IV Grantryl
Granisetron group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women undergoing cesarean section
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Links

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

FentanylBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Mohammed Youssef, postgarduate

CONTACT

01119727670moha4evercs22@gmail.com

Mostafa youssef

CONTACT

01008840458myoussefm23@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2022

First Posted

July 26, 2022

Study Start

June 1, 2022

Primary Completion

August 30, 2023

Study Completion

January 30, 2024

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)