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

Sohag University

Status: Unknown

Conditions: Perineal Surgery

Treatments: Drug: Ondansetron , atropine and bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05137288

00013006

Details and patient eligibility

About

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 .

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

patients receiving intrathecal atropine

Active Comparator group

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 .

Treatment:

Drug: Ondansetron , atropine and bupivacaine

patients receiving preoperative intravenous ondasetron

Active Comparator group

Description:

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 ) .

Treatment:

Drug: Ondansetron , atropine and bupivacaine