Intrathecal Dexamethasone and Atropine on Morphine Induced Post-operative Nausea and Vomiting on Caesarean Section

September 30, 2022 updated by: Ahmed Shaban Abd Elbadea Khalifa, Assiut University

Prophylactic Efficacy and Safety of Intrathecal Dexamethasone, Atropine or Their Combination on Morphine Induced Post-operative Nausea and Vomiting on Patients Undergoing Caesarean Section With Spinal Anaesthesia

Pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. Low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain. Morphine has many complications like post-operative nausea and vomiting (PONV). the investigators will investigate the utility of intrathecal (IT) atropine and dexamethasone for prevention of morphine induced PONV as a primary outcome in parturient undergoing CS under spinal bupivacaine anesthesia plus morphine sulfate as an adjuvant.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. Low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain in many surgical areas including Caesarean delivery. Morphine has many complications namely pruritus, and post-operative nausea and vomiting (PONV). The other risk factors for the development of PONV include female gender, non-smoker status, general anesthesia with inhalational anesthetics and surgical factors (duration and type of surgery). The supplementation of morphine, however raises the occurrences of postoperative nausea and vomiting (PONV) in these patient To tackle this problem, the investigators have to use the combination therapy of antiemetics like a serotonin receptor antagonist of either intravenous (IV) ondansetron or granisetron with IV dexamethasone is administered after the administration of intrathecal morphine. Dopamine receptor antagonists e.g. droperidol and metoclopramide are commonly used, but they carry the risk of extrapyramidal symptoms.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female
  2. 18-45 years old
  3. ASA: 1, 2
  4. Elective caesarean section under spinal anaesthesia.

Exclusion Criteria:

  1. Patient refusal.
  2. Contraindications to spinal anaesthesia as coagulopathy, infection at site of injection, hemodynamic instability and uncooperative patient.
  3. Contraindications to administration of morphine as asthmatic patient and hypersensitivity and contraindications to any of the study drugs.
  4. Adult-Emergency CS as there is no time for preparation and risk on fetus and mother for time consuming

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dexamethasone group (D)
Patients will receive intrathecal hyperbaric bupivacaine 0.5% in a dose of 12.5 mg (2.5 ml) mixed with morphine in a dose of 200 µg (0.5 ml was withdrawn from a syringe containing 4 mg morphine sulfate diluted in 10 ml normal saline) [Total volume 4 ml], followed by intrathecal dexamethasone 4 mg (1ml).
Drug: Atropine and Dexamethasone
Intrathecal dexamethasone, atropine or their combination.
Other: Atropine group (A)
Patients will receive intrathecal hyperbaric bupivacaine 12.5 mg (2.5 ml 0.5%) mixed with morphine 200 µg (0.5 ml) and atropine100 µg (0.5 ml was withdrawn from a syringe containing 2 mg atropine sulfate diluted in 10 ml normal saline) [Total volume 3.5 ml].
Drug: Atropine and Dexamethasone
Intrathecal dexamethasone, atropine or their combination.
Other: Dexamethasone and Atropine group (DA)
Patients will receive intrathecal hyperbaric bupivacaine in a dose of 12.5 mg (2.5 ml) mixed with morphine 200 µg (0.5 ml) and atropine 100 µg (0.5 ml), followed by intrathecal injection of dexamethasone 4 mg (1 ml) [Total volume 4.5 ml] .
Drug: Atropine and Dexamethasone
Intrathecal dexamethasone, atropine or their combination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of PONV
Time Frame: 24 hour

Incidence and severity of PONV by designing questionnaire and specific scale:

  1. no nausea or vomiting
  2. mild nausea and vomiting but no need to treatment
  3. moderate nausea and vomiting that need treatment
  4. severe form of nausea and vomiting and resistant to treatment
24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antiemetic
Time Frame: 24 hour
Total dose of post-operative rescue antiemetic (ondansetron in mg) for 24 hour
24 hour
Post-operative pain profile
Time Frame: 24 hour
Post-operative visual analog scale (1: no pain and 10: the most severe experienced pain ) for 24 hour.
24 hour
Incidence of Side Effects
Time Frame: 24 hour
Anticipated side effects as shivering and hypotension( number of patients and severity)
24 hour
Analgesia
Time Frame: 24 hour
Time to the first post-operative rescue analgesic for 24 hour.
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

September 17, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAD-PONV-SCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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