Clinical trial NCT03023306: Preemptive Versus Preventive Antiemetic Treatment
Official title: Effectiveness of Preemptive Versus Preventive Antiemetic Treatment in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized Double Blind Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 115
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: PONV (postoperative nausea vomiting combined)
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative nausea frequency and intensity
timeFrame: 24 hours
measure: postoperative vomiting frequency
timeFrame: 24 hours
measure: postoperative pain
timeFrame: 24 hours
measure: retching
timeFrame: 24 hours
measure: PONV (postoperative nausea vomiting combined)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio University Hospital
state: Attika
Study officials:
References:
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.
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, 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.
citation: 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.
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.
citation: 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.