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

Sponsor

Mohamed Youssef Mohamed (Other)

Overall Status

Recruiting

CT.gov ID

NCT05474001

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

11.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nausea and Vomiting, Postoperative	Drug: Fentanyl Drug: Bupivacain Drug: intravenous graniseton	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jan 30, 2023

Arms and Interventions

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.	Drug: Fentanyl 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.	Drug: intravenous graniseton 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.	Drug: Bupivacain 10mg bubivacain intrathecal (2ml) with 0.5 ml saline with no intrathecal fentanyl Other Names: IT mercaine

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.

Drug: Fentanyl

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.

Drug: intravenous graniseton

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.

Drug: Bupivacain

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

Other Names:

IT mercaine

Outcome Measures

Primary Outcome Measures

nausea and vomiting score in patient during caesarean delivery [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 )

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University Hospital	Sohag		Egypt

Sponsors and Collaborators

Mohamed Youssef Mohamed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Intrathecal Fentanyl Is Superior to Intravenous Ondansetron for the Prevention of Perioperative Nausea During Cesarean Delivery with Spinal Anesthesia

Publications

None provided.

Responsible Party:

Mohamed Youssef Mohamed, Principal Investigator, Sohag University

ClinicalTrials.gov Identifier:

NCT05474001

Other Study ID Numbers:

134896646

First Posted:

Jul 26, 2022

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Nausea

Vomiting

Postoperative Nausea and Vomiting

Fentanyl

Bupivacaine

Study Results

No Results Posted as of Jul 26, 2022