Granisetron vs Granisetron and Dexamethasone on the Reduction of Postoperative Nausea and Vomiting

NCT04570592 | Unknown Phase 2 DMC

• 1 other identifier: USM/JEPeM/1809426
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Intrathecal morphine (ITM) has proven to be excellent in reducing postoperative pain. However, its use has commonly been associated with the occurrence of postoperative nausea and vomiting (PONV). In recent years, the combination therapy of antiemetics comprising of a serotonin receptor antagonist and corticosteroid has been implemented to diminish the occurrence of PONV. Despite being routinely used, the evidence in the efficacy of this combination in parturients are conflicting and lacking. In this study, we wish to compare the efficacy between the combination therapy of granisetron plus dexamethasone versus granisetron alone on the occurrence of postoperative nausea and vomiting (PONV) in 126 parturients undergoing elective Caesarean delivery supplemented with intrathecal morphine.

Conditions

PONV

Keywords

Caesarean; Morphine; Granisetron

Outcome Measures

Primary Outcomes (1)

• Comparing the incidence of post operative nausea and vomiting (PONV)

  To compare the incidence of nausea, retching and vomiting at 1 hour, 4 hourly for 12 hours and at 24 hours postoperatively between parturients receiving combination therapy of Granisetron plus Dexamethasone versus that of Granisetron alone

  From 1 to 24 hour post operatively

Secondary Outcomes (1)

• Comparing the requirement of rescue antiemetic between both groups

  From 1 to 24 hour post operatively

Study Arms (2)

Granisetron

PLACEBO COMPARATOR

Granisetron 1 mg (1ml) + Normal saline 1ml

Drug: Granisetron 1 Mg/mL Intravenous Solution

Granisetron and Dexamethasone

EXPERIMENTAL

Granisetron 1mg (1ml) + Dexamethasone 4mg (1ml)

Drug: Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mg

Interventions

Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mg DRUG

Comparing PONV incidences in both arms

Also known as: Treatment group

Granisetron and Dexamethasone

Granisetron 1 Mg/mL Intravenous Solution DRUG

Comparing PONV incidences in both arms

Granisetron

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Parturients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anaesthesiologists (ASA) I-II category
• risks factors or more for PONV according to Apfel Score.

You may not qualify if:

• Unfit for spinal anaesthesia.
• Coagulopathy
• Uncorrected hypovolemia
• Indeterminate neurologic disease
• Infection at site of injection
• Raised intracranial pressure(ICP)
• Morbidly obese patients, BMI\> 40 kg/m2 according to ICD-10 (International Statistical Classification of Diseases 10)
• Patients allergic towards morphine.
• Contraindicated for antiemetics use
• Granisetron: allergy towards Granisetron, prolonged QT interval
• Ondansetron: allergy towards ondansetron, prolonged QT interval
• Dexamethasone: allergy towards Dexamethasone, uncontrolled Diabetes Mellitus (DM).

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Universiti Sains Malaysia, Health Campus

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

Related Publications (5)

• Gwirtz KH, Young JV, Byers RS, Alley C, Levin K, Walker SG, Stoelting RK. The safety and efficacy of intrathecal opioid analgesia for acute postoperative pain: seven years' experience with 5969 surgical patients at Indiana University Hospital. Anesth Analg. 1999 Mar;88(3):599-604. doi: 10.1097/00000539-199903000-00026.

  PMID: 10072014 BACKGROUND

• Sfeir S, Mansour N. Post operative analgesia with intrathecal morphine. Middle East J Anaesthesiol. 2005 Feb;18(1):133-9.

  PMID: 15830768 BACKGROUND

• Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.

  PMID: 10598635 BACKGROUND

• Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.

  PMID: 15190136 BACKGROUND

• Abouleish E, Rawal N, Fallon K, Hernandez D. Combined intrathecal morphine and bupivacaine for cesarean section. Anesth Analg. 1988 Apr;67(4):370-4.

  PMID: 3354872 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Granisetron; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Farah Nasuha Mohd Daut

  Universiti Sains Malaysia, Health Campus, Kubang Kerian, Kelantan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Anaesthetist

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: September 30, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)