The Effect of Intravenous Granisetron and Ondansetron in Patients Undergoing Cesarean Section

NCT04613726 | Completed Phase 3

• 1 other identifier: B.30.2.ATA.0.01.00/166
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared the effects of prophylactic intravenous (IV) infusion of ondansetron and granisetron before the spinal anesthesia on hemodynamic parameters in patients undergoing elective cesarean section.

Conditions

Vomiting, Postoperative; Postoperative Complications; Hypotension

Keywords

cesarean section; granisetron; ondansetron; spinal anesthesia; blood pressure; pre-treatment

Outcome Measures

Primary Outcomes (1)

• ephedrine requirement

  The change in ephedrine requirement during surgery (mg).

  Every two minutes during surgery.

Secondary Outcomes (4)

• atropine requirement

  every two minutes during surgery

• analgesic requirement

  every five minutes during surgery and postoperative 24 hours

• blood pressure values

  every two minutes during surgery

• heart rate values

  every two minutes during surgery

Study Arms (3)

IV 10 ml normal saline

PLACEBO COMPARATOR

Control group consisted of patients receiving IV 10 ml normal saline.

Drug: Saline

IV 8 mg ondansetron in 10 ml of normal saline

ACTIVE COMPARATOR

This group consisted of receiving IV 8 mg ondansetron diluted in 10 ml of normal saline,

Drug: ondansetron

IV 3 mg granisetron in 10 ml of normal saline

ACTIVE COMPARATOR

This group consisted of receiving IV 3 mg granisetron diluted in 10 ml of normal saline.

Drug: Granisetron

Interventions

ondansetron DRUG

group consisted of receiving IV 8 mg ondansetron diluted in 10 ml of normal saline

IV 8 mg ondansetron in 10 ml of normal saline

Granisetron DRUG

Another comparator group consisted of receivingIV 3 mg granisetron diluted in 10 ml of normal saline

IV 3 mg granisetron in 10 ml of normal saline

Saline DRUG

Control group consisted of patients receiving IV 10 ml normal saline

IV 10 ml normal saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women with uncomplicated term pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged between 18-45 years
• uncomplicated term pregnancy
• ASA (American society of anesthesiologist) I or II
• undergoing elective cesarean section with combined spinal-epidural anesthesia

You may not qualify if:

• psychiatric diseases
• preeclampsia
• pregnancy-induced hypertension
• chronic hypertension
• diabetes
• multiple pregnancies
• fetal anomaly
• allergy to study drugs
• receiving selective serotonin reuptake inhibitors

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Mehmet AKSOY

Erzurum, string:Turkey, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Postoperative Complications; Hypotension

Interventions

Ondansetron; Granisetron; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mehmet AKSOY, Assoc.Prof.

  Faculty of Medicine, Ataturk University, Erzurum, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist in charge, and the patient and investigators were blinded to the group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr. Mehmet AKSOY

Model Details: Comparator / control treatment Control group consisted of patients receiving IV 10 ml normal saline. A comparator group consisted of receiving IV 8 mg ondansetron diluted in 10 ml of normal saline, Another comparator group consisted of receivingIV 3 mg granisetron diluted in 10 ml of normal saline.

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 3, 2020
• Study Start: December 3, 2018
• Primary Completion: December 12, 2019
• Study Completion: January 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)