Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for the Prophylaxis of Postoperative Nausea and Vomiting (PONV) in Women Over 60 Years Undergoing Laparoscopic Cholecystectomy

NCT02541019 | Completed Phase 4 DMC

• 1 other identifier: 48149215.0.0000.5253
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the development of new drugs, nausea and vomiting after surgery (PONV) are still frequent. Antagonists 5HT3 receptors, such as ondansetron and palanosetron, are among the main characterized prophylactic agents in patients at high risk, however there are few studies comparing the efficacy of these drugs and no study that addresses women aged over 60 years. In this prospective, randomized, double-blind study, 80 women nonsmokers, undergoing laparoscopic cholecystectomy will be divided into two groups, receiving during anesthetic induction intravenous ondansetron 4 mg (n = 40) or palonosetron 75 mcg (n = 40) prophylaxis of PONV.

Conditions

Postoperative Nausea and Vomiting

Keywords

C23.888.821.712.700

Outcome Measures

Primary Outcomes (1)

• Frequency and intensity of individual episodes of PONV.

  48 h after surgery

Secondary Outcomes (7)

• Intensity of nausea

  during clinical visit 2, 6, 24 and 48 h postoperatively

• Need of medication for antiemetic rescue

  during the 48 h after surgery

• Number of complete responders to medication

  during the 48 h after surgery

• Degree of satisfaction with antiemetic therapy

  during the 48 h after surgery

• Cost of antiemetic medication

  during the 48 h after surgery

Study Arms (2)

Palonosetron

EXPERIMENTAL

Palonosetron (iv) one minute before anesthesic induction.

Drug: Palonosetron

Ondansetron

EXPERIMENTAL

ondansetron (iv) one minute before anesthesic induction and ondansetron regular three times a day for two days after the surgery.

Drug: Ondansetron

Interventions

Ondansetron DRUG

4 mg IV, one minute before the anesthesia induction and 4 mg IV three times a day during two days after the surgery.

Ondansetron

Palonosetron DRUG

75 mcg IV, one minute before the anesthesia induction.

Palonosetron

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Will be selected patients aged over 60 years, ASA 1-3 that are candidates for laparoscopic cholecystectomy

You may not qualify if:

• Participation in another study last month.
• Body mass index\> 35.
• The occurrence of episodes of nausea or vomiting in the last 24 h prior to surgery.
• Use of corticosteroids.
• Smoking.
• Alcoholism.
• Use of psychoactive drugs or any other drug with antiemetic effect.
• Known hypersensitivity to any study medication
• Severe diseases in organs such as kidney, liver, lung, heart, brain and bone marrow.
• Conversion laparoscopic cholecystectomy for conventional cholecystectomy.

Sponsors & Collaborators

• Hospital Federal de Bonsucesso: lead

Study Sites (1)

Hospital Federal de Bonsucesso

Rio de Janeiro, 21041-030, Brazil

Location

Related Publications (11)

• Horn CC, Wallisch WJ, Homanics GE, Williams JP. Pathophysiological and neurochemical mechanisms of postoperative nausea and vomiting. Eur J Pharmacol. 2014 Jan 5;722:55-66. doi: 10.1016/j.ejphar.2013.10.037. Epub 2013 Oct 26.

  PMID: 24495419 RESULT

• Silva AC, O'Ryan F, Poor DB. Postoperative nausea and vomiting (PONV) after orthognathic surgery: a retrospective study and literature review. J Oral Maxillofac Surg. 2006 Sep;64(9):1385-97. doi: 10.1016/j.joms.2006.05.024.

  PMID: 16916674 RESULT

• Grover VK, Mathew PJ, Hegde H. Efficacy of orally disintegrating ondansetron in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy: a randomised, double-blind placebo controlled study. Anaesthesia. 2009 Jun;64(6):595-600. doi: 10.1111/j.1365-2044.2008.05860.x.

  PMID: 19453311 RESULT

• Turkistani A, Abdullah K, Manaa E, Delvi B, Khairy G, Abdulghani B, Khalil N, Damas F, El-Dawlatly A. Effect of fluid preloading on postoperative nausea and vomiting following laparoscopic cholecystectomy. Saudi J Anaesth. 2009 Jul;3(2):48-52. doi: 10.4103/1658-354X.57872.

  PMID: 20532102 RESULT

• Oksuz H, Zencirci B, Ezberci M. Comparison of the effectiveness of metoclopramide, ondansetron, and granisetron on the prevention of nausea and vomiting after laparoscopic cholecystectomy. J Laparoendosc Adv Surg Tech A. 2007 Dec;17(6):803-8. doi: 10.1089/lap.2006.0243.

  PMID: 18158814 RESULT

• Rusch D, Eberhart LH, Wallenborn J, Kranke P. Nausea and vomiting after surgery under general anesthesia: an evidence-based review concerning risk assessment, prevention, and treatment. Dtsch Arztebl Int. 2010 Oct;107(42):733-41. doi: 10.3238/arztebl.2010.0733. Epub 2010 Oct 22.

  PMID: 21079721 RESULT

• Rueffert H, Thieme V, Wallenborn J, Lemnitz N, Bergmann A, Rudlof K, Wehner M, Olthoff D, Kaisers UX. Do variations in the 5-HT3A and 5-HT3B serotonin receptor genes (HTR3A and HTR3B) influence the occurrence of postoperative vomiting? Anesth Analg. 2009 Nov;109(5):1442-7. doi: 10.1213/ane.0b013e3181b2359b. Epub 2009 Aug 27.

  PMID: 19713259 RESULT

• Janicki PK, Sugino S. Genetic factors associated with pharmacotherapy and background sensitivity to postoperative and chemotherapy-induced nausea and vomiting. Exp Brain Res. 2014 Aug;232(8):2613-25. doi: 10.1007/s00221-014-3968-z. Epub 2014 May 4.

  PMID: 24792505 RESULT

• Trammel M, Roederer M, Patel J, McLeod H. Does pharmacogenomics account for variability in control of acute chemotherapy-induced nausea and vomiting with 5-hydroxytryptamine type 3 receptor antagonists? Curr Oncol Rep. 2013 Jun;15(3):276-85. doi: 10.1007/s11912-013-0312-x.

  PMID: 23512709 RESULT

• Choi YS, Shim JK, Yoon DH, Jeon DH, Lee JY, Kwak YL. Effect of ramosetron on patient-controlled analgesia related nausea and vomiting after spine surgery in highly susceptible patients: comparison with ondansetron. Spine (Phila Pa 1976). 2008 Aug 1;33(17):E602-6. doi: 10.1097/BRS.0b013e31817c6bde.

  PMID: 18670328 RESULT

• Apfel CC, Roewer N. Risk assessment of postoperative nausea and vomiting. Int Anesthesiol Clin. 2003 Fall;41(4):13-32. doi: 10.1097/00004311-200341040-00004. No abstract available.

  PMID: 14574212 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ondansetron; Palonosetron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines

Study Officials

• Ismar L Cavalcanti, PhD

  UFF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 4, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

BR (1)