Intrathecal Atropine to Prevent Postoperative Nausea and Vomiting

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT03387956

Collaborator

(none)

120

Enrollment

Location

Arms

4.7

Actual Duration (Months)

25.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea	Drug: Intrathecal atropine Drug: dexamethasone	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Intravenous Dexamethasone Combined With Intrathecal Atropine to Prevent Morphine-related Nausea and Vomiting After Cesarean Delivery: A Randomized Double-blinded Study

Actual Study Start Date :

Mar 20, 2017

Actual Primary Completion Date :

Jul 28, 2017

Actual Study Completion Date :

Aug 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Intrathecal atropine 100ug intrathecal atropine will be injected with spinal anesthesia
Active Comparator: 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).	Drug: dexamethasone intravenous 8 mg dexamethasone (2ml).
Active Comparator: 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.	Drug: Intrathecal atropine 100ug intrathecal atropine will be injected with spinal anesthesia Drug: dexamethasone intravenous 8 mg dexamethasone (2ml).

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Intrathecal atropine

100ug intrathecal atropine will be injected with spinal anesthesia

Active Comparator: 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).

Drug: dexamethasone

intravenous 8 mg dexamethasone (2ml).

Active Comparator: 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.

Drug: Intrathecal atropine

100ug intrathecal atropine will be injected with spinal anesthesia

Drug: dexamethasone

intravenous 8 mg dexamethasone (2ml).

Outcome Measures

Primary Outcome Measures

postoperative nausea [24 hours]
Monitoring scale of nausea and vomiting

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emad Zarief Kamel Said	Assiut		Egypt	71111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emad Zarief , MD, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT03387956

Other Study ID Numbers:

IRB00009916

First Posted:

Jan 2, 2018

Last Update Posted:

Jun 6, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Emad Zarief , MD, Dr, Assiut University

Postoperative Nuasea

Additional relevant MeSH terms:

Nausea

Vomiting

Postoperative Nausea and Vomiting

Dexamethasone

Atropine

Study Results

No Results Posted as of Jun 6, 2018