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

Not Applicable

• Conditions: Perineal Surgery
• Interventions: Drug: Ondansetron , atropine and bupivacaine

• Registration Number: NCT05137288
• Lead Sponsor: Sohag University

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-13
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-28
• Last Update Submitted: 2021-11-28
• Study First Posted: 2021-11-30
• Last Update Posted: 2021-11-30
• Study Start: 2021-12-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients receiving preoperative intravenous ondasetron	Ondansetron , atropine and bupivacaine	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 ) .
patients receiving intrathecal atropine	Ondansetron , atropine and bupivacaine	Patient received intrathecal hyperbaric bupivacaine ( 10 mg ) ( 2 ml 0.5% ) with morphine 250mic and atropine sulphate 100 micwith total volume = 2.5 ml .

Primary Outcome Measures

Name	Time	Method
frequency of attacks of postoperative nausea and vomiting	6-9 months	Intrathecal atropine versus preoperative intravenous ondasetron for prevention of postoperative nausea and vomiting due to intrathecal morphine

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt