Can prophylactic use of ondansetron prevent the incidence of pruritus (itching) and postoperative nausea and vomiting caused by morphine used during anesthesia?

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/01/005362
• Date of registration: 07-01-2015
• Prospective Registration: No
• Primary sponsor: Dr Ram Bhakta Koju
• Public title: Can prophylactic use of ondansetron prevent the incidence of pruritus (itching) and postoperative nausea and vomiting caused by morphine used during anesthesia?
• Scientific title: Prophylactic Administration of Ondansetron in Prevention of Intrathecal Morphine Induced Pruritus and Post-Operative Nausea and Vomiting in Patients Undergoing Caesarean Section.
• Date of first enrolment: 17-08-2008
• Target sample size: 50
• Recruitment status: Not Applicable
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10813
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Case Record Numbers Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: N/A

Countries of recruitment

Nepal

Contacts

• Name: Ram Bhakta Koju
• Affiliation: KIST Medical College

• Name: Ram Bhakta Koju
• Affiliation: KIST Medical College

Key inclusion & exclusion criteria

Inclusion criteria: Parturients of American Society of Anesthesiologists (ASA) class I or II physical status scheduled for caesarean delivery under spinal anaesthesia.
Exclusion criteria: 1) Patients with known allergy to ondansetron, bupivacaine or morphine.

2) Patients with pruritogenic systemic disease, a coexisting skin disorder or preexisting pregnancy induced pruritus.

3) Patients with any contraindication for spinal anesthesia.

4) Patients who refused to participate in the study.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Parturients of ASA class I or II physical status scheduled for cesarean delivery under spinal anesthesia.

Intervention(s)

Intervention1: Ondansetron: 4mg (2 ml) of ondansetron is given 30 minutes before the administration of spinal anesthesia and the patients were observed for its efficacy in reducing the intrathecal morphine-induced pruritus (used in spinal anesthesia)and post operative nausea and vomiting. 2 ml of normal saline is used as a placebo in placebo group.
Control Intervention1: Not Applicable: Not Applicable

Primary Outcome(s)

1) Incidence of pruritus and post operative nausea/vomiting

Timepoint: Every 15 minutes for first 4 hours followed by 8 and 24 hours post surgery

Secondary Outcome(s)

1) Onset and Duration of pruritus

2) Severity of pruritus

3)Severity of post operative nausea / vomitingTimepoint: Every 15 minutes for first 4 hours followed by 8 and 24 hours post surgery

Secondary ID(s)

NIL

Source(s) of Monetary Support

Principal Investigator self funded study with the infrastructure and other logistic support from the Patan Hospital

Ethics review

Status: Approved
Approval date: 01/08/2008
Contact:

IRC-PAHS (then, Office of Medical Director, Patan Hospital)