search
Back to results

Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intrathecal atropine
dexamethasone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea focused on measuring Postoperative Nuasea

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • females
  • 18-40 years of age
  • elective cesarean delivery under bupivacaine spinal anesthesia

Exclusion Criteria:

  • renal disease
  • preeclampsia
  • liver disease
  • cardiac disease
  • Coagulopathy
  • chronic cough
  • nausea
  • vomiting
  • patient refusal

Sites / Locations

  • Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Atropine group

Dexamethasone group

Dexamethasone and Atropine group

Arm Description

Atropine group (A): Patients received intrathecal heavy Marcaine, 2 ml, 0.5% plus 300 µg morphine and 100 µg atropine (0.5ml), and intravenous injection of 2ml normal saline.

Dexamethasone group (D): Patients received intrathecal heavy Marcaine 2 ml, 0.5% plus 300 µg morphine (0.5ml), and intravenous 8 mg dexamethasone (2ml).

Dexamethasone and Atropine group (DA): Patients received intrathecally as group A, plus intravenous injection of 2 ml, dexamethasone 8 mg. Postoperative follow-up of both nausea and vomiting was done over 24 hours postoperative.

Outcomes

Primary Outcome Measures

postoperative nausea
Monitoring scale of nausea and vomiting

Secondary Outcome Measures

Full Information

First Posted
December 20, 2017
Last Updated
June 4, 2018
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03387956
Brief Title
Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting
Official Title
Intravenous Dexamethasone Combined With Intrathecal Atropine to Prevent Morphine-related Nausea and Vomiting After Cesarean Delivery: A Randomized Double-blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
optimal postoperative pain control with intrathecal morphine, with proper prevention of postoperative nausea and vomiting. Dexamethasone, and or atropine could offer some protection against nausea and vomiting.
Detailed Description
One of the gold standards for analgesia following cesarean delivery is intrathecal morphine, which is not devoid of complications namely postoperative nausea and vomiting. We evaluated the antiemetic effect of intravenous dexamethasone combined with intrathecal atropine after cesarean delivery under spinal bupivacaine plus morphine anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea
Keywords
Postoperative Nuasea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atropine group
Arm Type
Active Comparator
Arm Description
Atropine group (A): Patients received intrathecal heavy Marcaine, 2 ml, 0.5% plus 300 µg morphine and 100 µg atropine (0.5ml), and intravenous injection of 2ml normal saline.
Arm Title
Dexamethasone group
Arm Type
Active Comparator
Arm Description
Dexamethasone group (D): Patients received intrathecal heavy Marcaine 2 ml, 0.5% plus 300 µg morphine (0.5ml), and intravenous 8 mg dexamethasone (2ml).
Arm Title
Dexamethasone and Atropine group
Arm Type
Active Comparator
Arm Description
Dexamethasone and Atropine group (DA): Patients received intrathecally as group A, plus intravenous injection of 2 ml, dexamethasone 8 mg. Postoperative follow-up of both nausea and vomiting was done over 24 hours postoperative.
Intervention Type
Drug
Intervention Name(s)
Intrathecal atropine
Intervention Description
100ug intrathecal atropine will be injected with spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
intravenous 8 mg dexamethasone (2ml).
Primary Outcome Measure Information:
Title
postoperative nausea
Description
Monitoring scale of nausea and vomiting
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: females 18-40 years of age elective cesarean delivery under bupivacaine spinal anesthesia Exclusion Criteria: renal disease preeclampsia liver disease cardiac disease Coagulopathy chronic cough nausea vomiting patient refusal
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting

We'll reach out to this number within 24 hrs