NCT03387956

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2017

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

December 20, 2017

Last Update Submit

June 4, 2018

Conditions

Postoperative Nausea

Keywords

Postoperative Nuasea

Outcome Measures

Primary Outcomes (1)

  • postoperative nausea

    Monitoring scale of nausea and vomiting

    24 hours

Study Arms (3)

Atropine group

ACTIVE COMPARATOR

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

Dexamethasone group

ACTIVE COMPARATOR

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

Dexamethasone and Atropine group

ACTIVE COMPARATOR

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 atropineDrug: dexamethasone

Interventions

Intrathecal atropineDRUG

100ug intrathecal atropine will be injected with spinal anesthesia

Atropine groupDexamethasone and Atropine group
dexamethasoneDRUG

intravenous 8 mg dexamethasone (2ml).

Dexamethasone and Atropine groupDexamethasone group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 20, 2017

First Posted

January 2, 2018

Study Start

March 20, 2017

Primary Completion

July 28, 2017

Study Completion

August 10, 2017

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

EG(1)