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

NCT ID: NCT05137288

Last Updated: 2021-11-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-08-01

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 .

Conditions

Perineal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients receiving intrathecal atropine

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

Group Type: ACTIVE_COMPARATOR

Ondansetron , atropine and bupivacaine

Intervention Type: DRUG

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 ) .

patients receiving preoperative intravenous ondasetron

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 ) .

Group Type: ACTIVE_COMPARATOR

Ondansetron , atropine and bupivacaine

Intervention Type: DRUG

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 ) .

Interventions

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 .

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 ) .

Intervention Type: DRUG

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Shehab Mahmoud Mohamed

resident doctor at anesthesia and ICU department sohag university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospital

Sohag, , Egypt

Countries

Egypt

Central Contacts

shehab m mohamed, resident

Role: CONTACT

Phone: 01147223196

Email: shehabmahmoud@med.sohag.edu.eg

elhadad a mousa, professor

Role: CONTACT

Facility Contacts

osama r elsherif, professor

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 15102380 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21730925 (View on PubMed)

Other Identifiers

00013006

Identifier Type: -

Identifier Source: org_study_id