Preemptive Versus Preventive Antiemetic Treatment

NCT03023306 | Unknown

• 1 other identifier: IRB No 65/19-06-18
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study. Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before the start of surgery or to the intraoperative group to receive the same antiemetic drugs in the same doses intraoperatively, 30 min before the end of surgery. In the operating room standard monitoring and a standardized anesthetic technique will be implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical rating scale) will be recorded at the same time points. Also, when patients received fluids and solid food by mouth will be recorded.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• PONV (postoperative nausea vomiting combined)

  Incidence of combined nausea and vomiting postoperatively

  24 hours

Secondary Outcomes (5)

• postoperative nausea frequency and intensity

  24 hours

• postoperative vomiting frequency

  24 hours

• postoperative pain

  24 hours

• retching

  24 hours

• PONV (postoperative nausea vomiting combined)

  24 hours

Study Arms (2)

preemptive group

ACTIVE COMPARATOR

The preemptive group will receive the anti-emetic regimen i.v. (4 mg of ondansetron) 1h before the start of surgery. During surgery, 30 min before the end of operation, this group will receive i.v. 0.9% NaCl in equal volumes.The intervention consists of the different time points of antiemetic treatment, thus 1h before surgery vs intraopertively. Intervention: Antiemetic treatment 1h before surgery

Other: Antiemetics perioperatively

intraoperative group

OTHER

The preventive group will receive i.v. 0.9% NaCl 1h before surgery and ondansetron 4 mg 30 min before the end of surgery at equal volumes. Intervention: Antiemetic treatment intraoperatively

Other: Antiemetics perioperatively

Interventions

Antiemetics perioperatively OTHER

Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively

intraoperative group; preemptive group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-III patients
• Surgical procedure: scheduled for laparoscopic cholecystectomy
• Type of anesthesia: general

You may not qualify if:

• Antihistamines the last three days
• Antiemetic drugs the last three days
• Hiatus hernia
• reflux
• Gastrointestinal disease
• Pregnancy
• BMI \> 35
• parkinson
• known allergy to the drugs of the protocol
• epilepsy

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Aretaieio University Hospital

Athens, Attica, 11528, Greece

Location

Related Publications (6)

• Odom-Forren J, Rayens MK, Gokun Y, Jalota L, Radke O, Hooper V, Wiggins AT, Apfel CC. The Relationship of Pain and Nausea in Postoperative Patients for 1 Week After Ambulatory Surgery. Clin J Pain. 2015 Oct;31(10):845-51. doi: 10.1097/AJP.0000000000000170.

  PMID: 25370136 BACKGROUND

• Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.

  PMID: 24356162 BACKGROUND

• Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.

  PMID: 23035051 BACKGROUND

• Apfel CC, Meyer A, Orhan-Sungur M, Jalota L, Whelan RP, Jukar-Rao S. Supplemental intravenous crystalloids for the prevention of postoperative nausea and vomiting: quantitative review. Br J Anaesth. 2012 Jun;108(6):893-902. doi: 10.1093/bja/aes138.

  PMID: 22593126 BACKGROUND

• Wallden J, Flodin J, Hultin M. Validation of a prediction model for post-discharge nausea and vomiting after general anaesthesia in a cohort of Swedish ambulatory surgery patients. Eur J Anaesthesiol. 2016 Oct;33(10):743-9. doi: 10.1097/EJA.0000000000000473.

  PMID: 27270883 BACKGROUND

• Theodosopoulou P, Staikou C, Fassoulaki A. Preoperative versus intraoperative antiemetic strategies in patients undergoing laparoscopic cholecystectomy: A randomised double-blind study. Eur J Anaesthesiol. 2023 Oct 1;40(10):769-776. doi: 10.1097/EJA.0000000000001888. Epub 2023 Jul 19.

  PMID: 37466110 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Argyro Fassoulaki, MD PhD DEAA

CONTACT

306936701333; afassou1@otenet.gr

Chryssoula Staikou, MD, PhD, DESA

CONTACT

00306932352742; c_staikou@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: November 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)