Comparison Between Drugs for Control of Emetic Attacks During Caesarean Delivery

NCT ID: NCT06300346

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-08-18

Brief Summary

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Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis.

Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia

Detailed Description

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Conditions

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Emetic Attacks During Caesarean Delivery With Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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propofol

30 Patients will receive propofol as equal volumes of both 1% of propofol 10mg/ml and0.9% normal saline will be drawn in a 20-ml syringe before spinal puncture.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Ondansetron

pregabalin

30 Patients will receive three capsules of pregabalin 100 mg once one hour before the surgical incision.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Ondansetron

ondansetron

30 Patients will receive 4 mg ondansetron in 10 ml saline intravenously 5 min before spinal puncture.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Ondansetron

Interventions

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Propofol

Ondansetron

Intervention Type DRUG

Other Intervention Names

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Pregabalin

Eligibility Criteria

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Inclusion Criteria

* Age: 21-40 years old.
* Physical status American Society of Anesthesiologists (ASA)I\&II.
* Body mass index (BMI) \< 35\&\>20 kg/m2.
* Elective uncomplicated cesarean section under spinal anesthesia.

Exclusion Criteria

* Patient refusal.
* Patients with known history of allergy to study drugs.
* Advanced hepatic, renal and respiratory diseases.
* Psychological and mental disorders.
* Patient with reduced level of consciousness.
* Hypertensive, cardiac, and diabetic patients.
* Patients receiving anticoagulants therapy or suspected coagulopathy.
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ebtehal Ahmed Abdellattif

resident at Anesthesiology, Surgical Intensive Care and Pain Medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ebtihal A Abd-Ellateef, resident

Role: CONTACT

01119925603

Ahmed M Abd-Elmaboud, assistant professor

Role: CONTACT

01150217744

References

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Hirmanpour A, Safavi M, Honarmand A, Hosseini AZ, Sepehrian M. The comparative study of intravenous Ondansetron and sub-hypnotic Propofol dose in control and treatment of intrathecal Sufentanil-induced pruritus in elective caesarean surgery. J Res Pharm Pract. 2015 Apr-Jun;4(2):57-63. doi: 10.4103/2279-042X.155751.

Reference Type BACKGROUND
PMID: 25984542 (View on PubMed)

Mokini Z, Genocchio V, Forget P, Petrini F. Metoclopramide and Propofol to Prevent Nausea and Vomiting during Cesarean Section under Spinal Anesthesia: A Randomized, Placebo-Controlled, Double-Blind Trial. J Clin Med. 2021 Dec 26;11(1):110. doi: 10.3390/jcm11010110.

Reference Type BACKGROUND
PMID: 35011852 (View on PubMed)

Athavale A, Athavale T, Roberts DM. Antiemetic drugs: what to prescribe and when. Aust Prescr. 2020 Apr;43(2):49-56. doi: 10.18773/austprescr.2020.011. Epub 2020 Apr 1.

Reference Type BACKGROUND
PMID: 32346211 (View on PubMed)

Elvir-Lazo OL, White PF, Yumul R, Cruz Eng H. Management strategies for the treatment and prevention of postoperative/postdischarge nausea and vomiting: an updated review. F1000Res. 2020 Aug 13;9:F1000 Faculty Rev-983. doi: 10.12688/f1000research.21832.1. eCollection 2020.

Reference Type BACKGROUND
PMID: 32913634 (View on PubMed)

Other Identifiers

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Soh-Med-23-12-02MS

Identifier Type: -

Identifier Source: org_study_id

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