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Intrathecal Fentanyl Versus Intravenous Granisetron for the Prevention of Perioperative Nausea and Vomiting During Cesarean Delivery under Spinal Anesthesia
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 :
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl group | Active Comparator | 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. |
|
| Granisetron group | Active Comparator | Patients will receive 10 mg hyperbaric Bupivacaine ( 2ml ) and 0.5 mL normal saline IT. 1 mg (1 mL) IV granisetron after spinal placement. |
|
| Control group | Placebo Comparator | 10 mg hyperbaric Bupivacaine ( 2ml ) IT and normal saline 0.5 ml 1 ml normal saline IV after spinal placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | 10mg bubivacain intrathecal ( 2ml ) with 20microgram intrathecal fentanyl |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 ) | six month |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women undergoing cesarean section
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Youssef, postgarduate | Contact | 01119727670 | moha4evercs22@gmail.com | |
| Mostafa youssef | Contact | 01008840458 | myoussefm23@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University Hospital | Recruiting | Sohag | Egypt |
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| Label | URL |
|---|---|
| Intrathecal Fentanyl Is Superior to Intravenous Ondansetron for the Prevention of Perioperative Nausea During Cesarean Delivery with Spinal Anesthesia | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 23, 2024 | |
| Reset | Jul 26, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 23, 2024 | Jul 26, 2024 |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
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| Bupivacain | Drug | 10mg bubivacain intrathecal (2ml) with 0.5 ml saline with no intrathecal fentanyl |
|
|
| intravenous graniseton | Drug | 10mg bubivacain intrathecal ( 2ml ) with 0.5 ml saline with no intrathecal fentanyl with 1mg iv granisetron |
|
|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |