Opioid-free Anesthesia in Gynecologic Surgery

Gynecologic Disease Clinical Trial

Official title:

Effect of Opioid-free General Anesthesia on Postoperative Nausea and Vomiting in Laparoscopic Gynecologic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04700761
• Other study ID #: B-2006-619-004
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: July 2022
• Source: Seoul National University Bundang Hospital
• Contact: Hyo-Seok Na
• Phone: +821087012913
• Email: hsknana[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Disease
• Postoperative Nausea and Vomiting

Intervention

Procedure:
• Opioid-free anesthesia
Anesthesia induction: thiopental, rocuronium, desflurane + single dose of alfentanil for endotracheal intubation Anesthesia maintenance: desflurane (without any opioid) Rescue for hypertension, tachycardia: desflurane and beta blocker/calcium channel blocker
• Opioid-using anesthesia
Anesthesia induction: thiopental, rocuronium, desflurane + continuous infusion of remifentanil (TCI, Minto model) Anesthesia maintenance: desflurane, remifentanil Rescue for hypertension, tachycardia: desflurane, remifantanil and beta blocker/calcium channel blocker

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra-operative blood pressure	Blood pressure (mmHg)	Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay)
Other	Intra-operative heart rate	Heart rate (bpm)	Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay)
Other	Hemodynamic drug intervention	Number of intervention	Intra-operative, day of surgery(during PACU stay)
Primary	Total incidence of post-operative nausea	Y/N	up to post-operative day 2
Secondary	Incidence of post-operative nausea	Y/N	day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Secondary	Severity of post-operative nausea	Grading: none, mild, moderate, severe	day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Secondary	Incidence of post-operative retching/vomiting	Y/N	day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Secondary	Rescue antiemetic agent use	Number of administration	day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Secondary	Post-operative pain score	Grading: 11-point numeric pain scale (0-10, 10 means the worst pain)	day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Secondary	Rescue pain medication use	Number of administration	day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2