Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting

NCT ID: NCT03387956

Last Updated: 2018-06-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2017-08-10

Brief Summary

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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

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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.

Conditions

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Postoperative Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Atropine group

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.

Group Type ACTIVE_COMPARATOR

Intrathecal atropine

Intervention Type DRUG

100ug intrathecal atropine will be injected with spinal anesthesia

Dexamethasone group

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

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type DRUG

intravenous 8 mg dexamethasone (2ml).

Dexamethasone and Atropine group

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.

Group Type ACTIVE_COMPARATOR

Intrathecal atropine

Intervention Type DRUG

100ug intrathecal atropine will be injected with spinal anesthesia

dexamethasone

Intervention Type DRUG

intravenous 8 mg dexamethasone (2ml).

Interventions

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Intrathecal atropine

100ug intrathecal atropine will be injected with spinal anesthesia

Intervention Type DRUG

dexamethasone

intravenous 8 mg dexamethasone (2ml).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Emad Zarief , MD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Emad Zarief Kamel Said

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB00009916

Identifier Type: -

Identifier Source: org_study_id

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