Intrathecal Atropine vs IV Metoclopramide for Nausea & Vomiting During CS

NCT03932578 | Completed Phase 4

• 1 other identifier: MSA10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the prophylactic use of low dose atropine and comparing it to metoclopramide for reducing intraoperative nausea and vomiting during cesarean section under spinal anesthesia

Conditions

Nausea; Vomiting

Keywords

Cesarean section; Nausea and vomiting; Spinal Anesthesia

Outcome Measures

Primary Outcomes (2)

• Intraoperative nausea and vomiting (IONV)

  Spontaneous reporting of IONV by patients, as well as any clinical manifestations (retching or vomiting) and any requests for antiemetic medication will be considered as episodes of NV

  During CS

• Postoperative nausea and vomiting (PONV)

  Spontaneous reporting of PONV by patients during scheduled interviews, as well as any clinical manifestations (retching or vomiting) and any requests for antiemetic medication will be considered as episodes of NV

  12 hours after CS

Secondary Outcomes (2)

• Time of requiring antiemetics

  Until 12 hours postoperatively

• Number of requiring antiemetics

  Until 12 hours postoperatively

Study Arms (2)

Atropine group

ACTIVE COMPARATOR

Patients will receive IV study solution which is 2 ml saline 0.9% as a placebo + intrathecal study solution which is a premised solution of 2.5 ml of 0.5% hyperbaric bupivacaine, 25 μg fentanyl and 100 μg of a 1 mg/ml preservative-free atropine sulfate solution

Drug: Atropine sulfate

Metoclopramide group

ACTIVE COMPARATOR

Patients in will receive IV study solution which is metoclopramide 10 mg in 2 ml + intrathecal study solution which is a premised solution of 2.5 ml of 0.5% hyperbaric bupivacaine, 25 μg fentanyl and 100 μg of preservative-free saline 0.9% as a placebo

Drug: Metoclopramide

Interventions

Atropine sulfate DRUG

Patients will receive intrathecal 100 μg of a 1 mg/ml preservative-free atropine sulfate solution

Atropine group

Metoclopramide DRUG

Patients will receive IV metoclopramide 10 mg in 2 ml

Metoclopramide group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with ASA physical status class I or II; indications for CS other than fetal or maternal pathology and surgery scheduled for within 4 days of physiological term will be included in this study

You may not qualify if:

• Height \< 150 or \> 180 cm
• Body mass index (BMI) \>35 kg/m2
• Active labor or emergency CS
• Emesis gravidarum
• Multifetal pregnancy
• Fetal distress
• Associated medical problem with pregnancy (as hypertension, diabetes mellitus, hepatic impairment or renal impairment)
• Obstetric problem (as placenta previa or placental abruption)
• Contraindication for central neuraxial block
• History of adverse reaction to any study medication
• History of antiemetic drug use
• Refusal to undergo regional anesthesia

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Atropine; Metoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Tamer Elmetwally, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Mohamed S Abdelhafez, MD

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 30, 2019
• Study Start: May 5, 2019
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication and forever
• Access Criteria: Contact to corresponding author

Locations

EG (1)