Comparison Between IT Fentanyl and IV Granisetron in Prevention of Vomiting in CS Under Spinal Anesthesia
NCT ID: NCT05474001
Last Updated: 2023-04-18
Study Results
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Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2022-06-01
2024-01-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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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.
Fentanyl
10mg bubivacain intrathecal ( 2ml ) with 20microgram intrathecal fentanyl
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.
intravenous graniseton
10mg bubivacain intrathecal ( 2ml ) with 0.5 ml saline with no intrathecal fentanyl with 1mg iv granisetron
Control group
10 mg hyperbaric Bupivacaine ( 2ml ) IT and normal saline 0.5 ml
1 ml normal saline IV after spinal placement.
Bupivacain
10mg bubivacain intrathecal (2ml) with 0.5 ml saline with no intrathecal fentanyl
Interventions
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Fentanyl
10mg bubivacain intrathecal ( 2ml ) with 20microgram intrathecal fentanyl
Bupivacain
10mg bubivacain intrathecal (2ml) with 0.5 ml saline with no intrathecal fentanyl
intravenous graniseton
10mg bubivacain intrathecal ( 2ml ) with 0.5 ml saline with no intrathecal fentanyl with 1mg iv granisetron
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Mohamed Youssef Mohamed
OTHER
Responsible Party
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Mohamed Youssef Mohamed
Principal Investigator
Locations
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Sohag University Hospital
Sohag, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Intrathecal Fentanyl Is Superior to Intravenous Ondansetron for the Prevention of Perioperative Nausea During Cesarean Delivery with Spinal Anesthesia
Other Identifiers
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134896646
Identifier Type: -
Identifier Source: org_study_id
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