Clinical trial NCT04700761: Opioid-free Anesthesia in Gynecologic Surgery
Official title: Effect of Opioid-free General Anesthesia on Postoperative Nausea and Vomiting in Laparoscopic Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Disease
Keywords: Analgesics, opioid
Postoperative nausea
Laparoscopy
Gynecologic surgical procedures
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 164
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Post-operative nausea and vomiting (PONV) is common for the patients undergoing laparoscopic gynecologic surgery. PONV is a major factor for patient dissatisfaction, delayed patient recovery and increased medical expenses. Opioid-reducing anesthetic regimen is known to decrease PONV and facilitate early recovery after surgery (ERAS) and has been widely accepted recently. In this study, the researchers intend to investigate whether opioid-free anesthesia effectively reduces PONV, and whether it is clinically safe and feasible.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for laparoscopic gynecologic surgery (≥90 min) for benign or malignant uterine/ovarian disease
* Age ≥ 19
* ASA (American Society of Anesthesiologists) class I-II

Exclusion Criteria:

* Uncontrolled hypertension
* Untreated intracranial aneurysm
* Severely impaired renal or hepatic function
* Pregnancy
* History of hypersensitivity for drugs used in the study
* Patients not using NSAID-containing IV PCA (patient controlled analgesia) device post-operatively

Primary outcomes:
measure: Total incidence of post-operative nausea
timeFrame: up to post-operative day 2
Secondary outcomes:
measure: Incidence of post-operative nausea
timeFrame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
measure: Severity of post-operative nausea
timeFrame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
measure: Incidence of post-operative retching/vomiting
timeFrame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
measure: Rescue antiemetic agent use
timeFrame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
measure: Post-operative pain score
timeFrame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
measure: Rescue pain medication use
timeFrame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Other outcomes:
measure: Intra-operative blood pressure
timeFrame: Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay)
measure: Intra-operative heart rate
timeFrame: Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay)
measure: Hemodynamic drug intervention
timeFrame: Intra-operative, day of surgery(during PACU stay)
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gyeonggi
Study officials:
References: