Nausea and Vomiting, PostoperativeNCT05474001
Comparison Between IT Fentanyl and IV Granisetron in Prevention of Vomiting in CS Under Spinal Anesthesia
A study testing Fentanyl, Bupivacain and intravenous graniseton in people with Nausea and Vomiting, Postoperative, run by Mohamed Youssef Mohamed at 1 site in Egypt.
Trial summary
Intrathecal Fentanyl Versus Intravenous Granisetron for the Prevention of Perioperative Nausea and Vomiting During Cesarean Delivery under Spinal Anesthesia Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Nausea and Vomiting, Postoperative
- What is being tested?
- Fentanyl, Bupivacain and intravenous graniseton
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- physical status I or II according to ASA classification with age between ( 18 - 45 years ) undergoing cesarean delivery under spinal anesthesia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama Elsherief, 0934602963, portal@med.sohag.edu.eg
About this study
Official title: Intrathecal Fentanyl Versus Intravenous Granisetron for the Prevention of Perioperative Nausea and Vomiting During Cesarean Delivery Under Spinal Anesthesia
Intrathecal Fentanyl Versus Intravenous Granisetron for the Prevention of Perioperative Nausea and Vomiting During Cesarean Delivery under Spinal Anesthesia
Read the 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
- Conditions
- Nausea and Vomiting, Postoperative
- Being tested
- Fentanyl, Bupivacain, intravenous graniseton
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called IT Fentanyl
10mg bubivacain intrathecal ( 2ml ) with 20microgram intrathecal fentanyl
BupivacainDrug
Also called IT mercaine
10mg bubivacain intrathecal (2ml) with 0.5 ml saline with no intrathecal fentanyl
intravenous granisetonDrug
Also called IV Grantryl
10mg bubivacain intrathecal ( 2ml ) with 0.5 ml saline with no intrathecal fentanyl with 1mg iv granisetron
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fentanyl |
| 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. Receives: Drug: intravenous graniseton |
| Control group | Placebo comparator | 10 mg hyperbaric Bupivacaine ( 2ml ) IT and normal saline 0.5 ml
1 ml normal saline IV after spinal placement. Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jun 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Youssef Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Youssef Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474001
- Sponsor's protocol ID
- 134896646
- Status last verified
- Apr 2023
- First submitted
- 24 Jun 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Fentanyl Versus Intravenous Granisetron for the Prevention of Perioperative Nausea and Vomiting During Cesarean Delivery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05474001
- Acronym / sponsor ID
- 134896646
- Conditions
- Nausea and Vomiting, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mohamed Youssef MohamedUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fentanyl group | Active comparator | Drug: FentanylPatients 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 | Drug: intravenous granisetonPatients 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 | Drug: Bupivacain10 mg hyperbaric Bupivacaine ( 2ml ) IT and normal saline 0.5 ml 1 ml normal saline IV after spinal placement. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- physical status I or II according to ASA classification with age between ( 18 - 45 years ) undergoing cesarean delivery under spinal anesthesia.
Key exclusion criteria (7 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: IT Fentanyl10mg bubivacain intrathecal ( 2ml ) with 20microgram intrathecal fentanyl | Drug | Fentanyl group |
| BupivacainAlso: IT mercaine10mg bubivacain intrathecal (2ml) with 0.5 ml saline with no intrathecal fentanyl | Drug | Control group |
| intravenous granisetonAlso: IV Grantryl10mg bubivacain intrathecal ( 2ml ) with 0.5 ml saline with no intrathecal fentanyl with 1mg iv granisetron | Drug | Granisetron group |
Primary outcome
nausea and vomiting score in patient during caesarean delivery
Time frame: 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 )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Intrathecal Fentanyl Is Superior to Intravenous Ondansetron for the Prevention of Perioperative Nausea During Cesarean Delivery with Spinal AnesthesiaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl, Bupivacain and intravenous graniseton in people with Nausea and Vomiting, Postoperative, run by Mohamed Youssef Mohamed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Youssef, postgarduate (01119727670, moha4evercs22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nausea and vomiting score in patient during caesarean delivery (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.