Clinical trial NCT00892996: Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
PONV
Keywords: Intrathecal morphine
Cesarean section
Nausea and vomiting
Prevention
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-05-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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

Eligibility criteria: 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

Primary outcomes:
measure: nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section
timeFrame: 24 hrs post operatively
Secondary outcomes:
measure: Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction
timeFrame: 24 Hrs post operatively
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology department, Siriraj hospital, Mahidol University
Study officials:
affiliation: Anesthesiology department, Siriraj hospital, Mahidol University
name: Patchareya Nivatpumin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu JI, Lo Y, Chia YY, Liu K, Fong WP, Yang LC, Tan PH. Prevention of postoperative nausea and vomiting after intrathecal morphine for Cesarean section: a randomized comparison of dexamethasone, droperidol, and a combination. Int J Obstet Anesth. 2007 Apr;16(2):122-7. doi: 10.1016/j.ijoa.2006.11.004. Epub 2007 Feb 1.
citation: Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.