NCT05474001

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Mohamed Youssef Mohamed · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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 : 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

Conditions

• Nausea and Vomiting, Postoperative

Interventions

Type	Name	Description
DRUG	Fentanyl	10mg bubivacain intrathecal ( 2ml ) with 20microgram intrathecal fentanyl
DRUG	Bupivacain	10mg bubivacain intrathecal (2ml) with 0.5 ml saline with no intrathecal fentanyl
DRUG	intravenous graniseton	10mg bubivacain intrathecal ( 2ml ) with 0.5 ml saline with no intrathecal fentanyl with 1mg iv granisetron

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-08-30
• Completion: 2024-01-30
• First posted: 2022-07-26
• Last updated: 2023-04-18

Locations

1 site across 1 country: Egypt