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

• ClinicalTrials.gov Identifier: NCT00892996
• Recruitment Status: Unknown
• First Posted: May 5, 2009
• Last Update Posted: May 5, 2009
• Sponsor: Mahidol University
• Information provided by: Mahidol University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy; PONV	Drug: dexamethasone; Drug: dexamethasone 5 mg	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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 Start Date: May 2009
• Estimated Primary Completion Date: April 2010
• Estimated Study Completion Date: April 2011

Arms and Interventions

Arm	Intervention/treatment
No Intervention: 1; Metoclopramide 10 mg intravenous
No Intervention: 2; Ondansetron 8 mg intravenous
Active Comparator: 3; dexamethasone 5 mg and metoclopramide 10 mg	Drug: dexamethasone; Metoclopramide 10 mg and dexamethasone 5 mg intravenous; Other Name: Dexamo
Active Comparator: 4; dexamethasone 5 mg and ondansetron 8 mg IV	Drug: dexamethasone 5 mg; Ondansetron 8 mg and dexamethasone 5 mg IV; Other Name: Dexamo

Outcome Measures

Primary Outcome Measures :

1. nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section [ Time Frame: 24 hrs post operatively ]

Secondary Outcome Measures :

1. Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction [ Time Frame: 24 Hrs post operatively ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Thailand

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, Thailand, 10700

Sponsors and Collaborators

Mahidol University

Investigators

• Principal Investigator: Patchareya Nivatpumin, M.D.; Anesthesiology department, Siriraj hospital, Mahidol University

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Siriraj institutional review board, mahidol university
• ClinicalTrials.gov Identifier: NCT00892996
• Other Study ID Numbers: Si 9091/2552(EC2)
• First Posted: May 5, 2009
• Last Update Posted: May 5, 2009
• Last Verified: May 2009

Keywords provided by Mahidol University:

Intrathecal morphine; Cesarean section; Nausea and vomiting; Prevention

Additional relevant MeSH terms:

Nausea; Vomiting; Postoperative Nausea and Vomiting; Signs and Symptoms, Digestive; Postoperative Complications; Pathologic Processes; Dexamethasone; Dexamethasone acetate; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action