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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04700761
Other study ID # B-2006-619-004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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