Clinical trial NCT05474001: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Nausea and Vomiting, Postoperative
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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 :

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

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

Primary outcomes:
measure: nausea and vomiting score in patient during caesarean delivery
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References: