Back to results

Intrathecal Atropine Versus Intravenous Ondasetron in Post Operative Nausea Due to Intrathecal Morphine

Primary Purpose

Perineal Surgery

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Ondansetron , atropine and bupivacaine

About this trial

This is an interventional treatment trial for Perineal Surgery

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age between ( 18 - 45 ) years.
Body mass index between ( 18.5 - 35 )
patients undergoing perineal surgery as anal fissure , piles and rectocele
patients receiving bupivacaine ( 20 mg / 4 ml ) as spinal anesthesia
Patinets with physical status 1 or 2 according to ASA classification

Exclusion Criteria:

Patient refusal .
Any contraindication of neuraxial block as : coagulopathy , skin infection at injection site or bacteremia , hypovolemia and shock , history of allergy to L.A , sever aortic stenosis or mitral stenosis ……… etc
Patients with physical status other than 1 and 2 according to ASA classification
Those with history of nausea and vomiting , also those who received anti emetic drugs in last 2 hours of operation .
Allergy to any of the drug included in this study .

Sites / Locations

Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

patients receiving intrathecal atropine

patients receiving preoperative intravenous ondasetron

Arm Description

Patient received intrathecal hyperbaric bupivacaine ( 10 mg ) ( 2 ml 0.5% ) with morphine 250mic and atropine sulphate 100 micwith total volume = 2.5 ml .

Patient received intrathecal hyperbaric bupivacaine ( 10 mg ) ( 2 ml 0.5% with 0.5 ml normal saline with morphine 250 mic ) with total volume = 2.5 ml with giving 4 mg IV ondansetron before anesthesia ( patients with body weight more than 80 Kg may need additional 4 mg IV ) .

Outcomes

Primary Outcome Measures

frequency of attacks of postoperative nausea and vomiting

Intrathecal atropine versus preoperative intravenous ondasetron for prevention of postoperative nausea and vomiting due to intrathecal morphine

Secondary Outcome Measures

Full Information

NCT ID

NCT05137288

First Posted

October 13, 2021

Last Updated

November 28, 2021

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05137288

Brief Title

Intrathecal Atropine Versus Intravenous Ondasetron in Post Operative Nausea Due to Intrathecal Morphine

Official Title

Intrathecal Atropine Versus Preoperative Intravenous Ondasetron for Prevention of Postoperative Nausea and Vomiting Due to Intrathecal Morphine in Perineal Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2021 (Anticipated)

Primary Completion Date

May 1, 2022 (Anticipated)

Study Completion Date

August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

To compare between intrathecal atropine versus preoperative administration of IV ondansetron in decreasing incidence of post operative nausea and vomiting related to intrathecal opioids in post operative period in perineal surgery as regard : efficacy and side effects .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perineal Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patients receiving intrathecal atropine

Arm Type

Active Comparator

Arm Description

Patient received intrathecal hyperbaric bupivacaine ( 10 mg ) ( 2 ml 0.5% ) with morphine 250mic and atropine sulphate 100 micwith total volume = 2.5 ml .

Arm Title

patients receiving preoperative intravenous ondasetron

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ondansetron , atropine and bupivacaine

Intervention Description

Patient received intrathecal hyperbaric bupivacaine ( 10 mg ) ( 2 ml 0.5% ) with morphine 250mic and atropine sulphate 100 micwith total volume = 2.5 ml . Patient received intrathecal hyperbaric bupivacaine ( 10 mg ) ( 2 ml 0.5% with 0.5 ml normal saline with morphine 250 mic ) with total volume = 2.5 ml with giving 4 mg IV ondansetron before anesthesia ( patients with body weight more than 80 Kg may need additional 4 mg IV ) .

Primary Outcome Measure Information:

Title

frequency of attacks of postoperative nausea and vomiting

Description

Intrathecal atropine versus preoperative intravenous ondasetron for prevention of postoperative nausea and vomiting due to intrathecal morphine

Time Frame

6-9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between ( 18 - 45 ) years. Body mass index between ( 18.5 - 35 ) patients undergoing perineal surgery as anal fissure , piles and rectocele patients receiving bupivacaine ( 20 mg / 4 ml ) as spinal anesthesia Patinets with physical status 1 or 2 according to ASA classification Exclusion Criteria: Patient refusal . Any contraindication of neuraxial block as : coagulopathy , skin infection at injection site or bacteremia , hypovolemia and shock , history of allergy to L.A , sever aortic stenosis or mitral stenosis ……… etc Patients with physical status other than 1 and 2 according to ASA classification Those with history of nausea and vomiting , also those who received anti emetic drugs in last 2 hours of operation . Allergy to any of the drug included in this study .

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

shehab m mohamed, resident

Phone

01147223196

shehabmahmoud@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

elhadad a mousa, professor

Facility Information:

Facility Name

Sohag University Hospital

City

Sohag

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

osama r elsherif, professor

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15102380

Citation

Gybels J, Erdine S, Maeyaert J, Meyerson B, Winkelmuller W, Augustinsson L, Bonezzi C, Brasseur L, DeJongste M, Kupers R, Marchettini P, Muller-Schwefe G, Nitescu P, Plaghki L, Reig E, Spincemaille G, Thomson S, Tronnier V, Van Buyten JP. Neuromodulation of pain. A consensus statement prepared in Brussels 16-18 January 1998 by the following task force of the European Federation of IASP Chapters (EFIC). Eur J Pain. 1998;2(3):203-9. doi: 10.1016/s1090-3801(98)90016-7. No abstract available.

Results Reference

background

PubMed Identifier

21730925

Citation

Baciarello M, Cornini A, Zasa M, Pedrona P, Scrofani G, Venuti FS, Fanelli G. Intrathecal atropine to prevent postoperative nausea and vomiting after Cesarean section: a randomized, controlled trial. Minerva Anestesiol. 2011 Aug;77(8):781-8.

Results Reference

background

Learn more about this trial

Intrathecal Atropine Versus Intravenous Ondasetron in Post Operative Nausea Due to Intrathecal Morphine

We'll reach out to this number within 24 hrs