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Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section

Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section: a Randomized Comparison of Metoclopramide or Ondansetron Alone or in the Combination With Dexamethasone.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00892996
Enrollment
120
Registered
2009-05-05
Start date
2009-05-31
Completion date
2011-04-30
Last updated
2009-05-05

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

Conditions

PONV, Pregnancy

Keywords

Intrathecal morphine, Cesarean section, Nausea and vomiting, Prevention

Brief summary

Post-operative nausea and vomiting are the major complications after spinal anesthesia with intrathecal morphine, therefore antiemetic drugs should be administered for best satisfaction of anesthesia to prevent these complication. Furthermore, administration of a combination of antiemetic drugs with different mechanisms of action appears reasonable and synergistic effect of drugs. In conclusion, we study efficacy of antiemetic effect of single antiemetic drug compare with combination antiemetic drugs.

Detailed description

In this study : a randomized, double-blind, placebo-controlled, clinical trial comparing single doses of Metoclopramide 10 mg and Ondansetron 8 mg alone and a combination of Dexamethasone 5 mg and Metoclopramide 10 mg or a combination of Dexamethasone 5 mg and Ondansetron 8 mg for prevention of PONV after spinal morphine for cesarean section. Inclusion criteria 1. Patient undergoes elective cesarean section age more than 18 years 2. Patient accepted in spinal anesthesia technique 3. ASA classification I-II 4. Patient understand question and evaluation process Exclusion criteria 1. Hyperemesis gravidarum 2. Patient with ongoing antiemetic drugs treatment 3. Patient with history of drug allergy in Metoclopramide,Ondansetron and Dexamethasone Outcome measurement By oral interview and nurse notification in 24 hr. post-operatively. Detail of outcome measurement 1. Nausea and vomiting score 2. Pain score 3. Sedation score 4. Itch symptom 5. Patient satisfaction

Interventions

DRUGdexamethasone

Metoclopramide 10 mg and dexamethasone 5 mg intravenous

DRUGdexamethasone 5 mg

Ondansetron 8 mg and dexamethasone 5 mg IV

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Pregnancy patients undergo Elective cesarean section age more than 18 years * Patient accept spinal anesthesia technique * ASA classification I-II * Patient understand question and evaluation process

Exclusion criteria

* Hyperemesis gravidarum * Patient ongoing treatment with antiemetic drugs * Allergy to Metoclopramide,Ondansetron and Dexamethasone

Design outcomes

Primary

MeasureTime frame
nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section24 hrs post operatively

Secondary

MeasureTime frame
Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction24 Hrs post operatively

Countries

Thailand

Outcome results

None listed

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