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

Primary Purpose

Nausea and Vomiting, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fentanyl
Bupivacain
intravenous graniseton
Sponsored by
Mohamed Youssef Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea and Vomiting, Postoperative

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Fentanyl group

Granisetron group

Control group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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 )

Secondary Outcome Measures

Full Information

First Posted
June 24, 2022
Last Updated
April 17, 2023
Sponsor
Mohamed Youssef Mohamed
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1. Study Identification

Unique Protocol Identification Number
NCT05474001
Brief Title
Comparison Between IT Fentanyl and IV Granisetron in Prevention of Vomiting in CS Under Spinal Anesthesia
Official Title
Intrathecal Fentanyl Versus Intravenous Granisetron for the Prevention of Perioperative Nausea and Vomiting During Cesarean Delivery Under Spinal Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Youssef Mohamed

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Intrathecal Fentanyl Versus Intravenous Granisetron for the Prevention of Perioperative Nausea and Vomiting During Cesarean Delivery under Spinal Anesthesia
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 : 20G IV line ( cannula ) will be inserted . Putting of patient on monitor and assessment of hemodynamics ( HR , RR , BP ) . Pre anesthetic hydration by at least 1000 ml ringer lactate Patient received Spinal anesthesia at level L3-L4 or L4-L5 lumbar segement . 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 . 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Granisetron group
Arm Type
Active Comparator
Arm Description
Patients will receive 10 mg hyperbaric Bupivacaine ( 2ml ) and 0.5 mL normal saline IT. 1 mg (1 mL) IV granisetron after spinal placement.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
10 mg hyperbaric Bupivacaine ( 2ml ) IT and normal saline 0.5 ml 1 ml normal saline IV after spinal placement.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
IT Fentanyl
Intervention Description
10mg bubivacain intrathecal ( 2ml ) with 20microgram intrathecal fentanyl
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Other Intervention Name(s)
IT mercaine
Intervention Description
10mg bubivacain intrathecal (2ml) with 0.5 ml saline with no intrathecal fentanyl
Intervention Type
Drug
Intervention Name(s)
intravenous graniseton
Other Intervention Name(s)
IV Grantryl
Intervention Description
10mg bubivacain intrathecal ( 2ml ) with 0.5 ml saline with no intrathecal fentanyl with 1mg iv granisetron
Primary Outcome Measure Information:
Title
nausea and vomiting score in patient during caesarean delivery
Description
: 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 )
Time Frame
six month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women undergoing cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Youssef, postgarduate
Phone
01119727670
Email
moha4evercs22@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa youssef
Phone
01008840458
Email
myoussefm23@gmail.com
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama Elsherief
Phone
0934602963
Email
portal@med.sohag.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://journals.lww.com/anesthesia-analgesia/fulltext/2000/05000/intrathecal_fentanyl_is_superior_to_intravenous.30.aspx
Description
Intrathecal Fentanyl Is Superior to Intravenous Ondansetron for the Prevention of Perioperative Nausea During Cesarean Delivery with Spinal Anesthesia

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

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