Preemptive Versus Preventive Antiemetic Treatment

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Effectiveness of Preemptive Versus Preventive Antiemetic Treatment in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized Double Blind Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03023306
• Other study ID #: IRB No 65/19-06-18
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: November 2020

Study information

• Verified date: October 2018
• Source: University of Athens
• Contact: Argyro Fassoulaki, MD PhD DEAA
• Phone: 306936701333
• Email: afassou1[@]otenet.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 115
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA physical status I-III patients

• Surgical procedure: scheduled for laparoscopic cholecystectomy

• Type of anesthesia: general

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Other:
• Antiemetics perioperatively
Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively

Locations

Country	Name	City	State
Greece	Aretaieio University Hospital	Athens	Attika

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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, Tramèr 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. Erratum in: Anesth Analg. 2015 Feb;120(2):494. Anesth Analg. 2014 Mar;118(3):689. — View Citation

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. — View Citation

Walldén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PONV (postoperative nausea vomiting combined)	Incidence of combined nausea and vomiting postoperatively	24 hours
Secondary	postoperative nausea frequency and intensity	numerical rating scale of nausea intensity (0-10)	24 hours
Secondary	postoperative vomiting frequency	number of vomits	24 hours
Secondary	postoperative pain	numerical rating scale of pain intensity (0-10)	24 hours
Secondary	retching	if retching exists	24 hours
Secondary	PONV (postoperative nausea vomiting combined)	frequency and intensity of nausea and vomiting	24 hours