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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05137288
Enrollment
100
Registered
2021-11-30
Start date
2021-12-01
Completion date
2022-08-01
Last updated
2021-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineal Surgery

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 .

Interventions

DRUGOndansetron , 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 ) .

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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 .

Design outcomes

Primary

MeasureTime frameDescription
frequency of attacks of postoperative nausea and vomiting6-9 monthsIntrathecal atropine versus preoperative intravenous ondasetron for prevention of postoperative nausea and vomiting due to intrathecal morphine

Countries

Egypt

Contacts

Primary Contactshehab m mohamed, resident
shehabmahmoud@med.sohag.edu.eg01147223196
Backup Contactelhadad a mousa, professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026