Gynecologic Disease
Conditions
Keywords
Analgesics, opioid, Postoperative nausea, Laparoscopy, Gynecologic surgical procedures
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.
Interventions
PROCEDUREOpioid-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
PROCEDUREOpioid-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
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total incidence of post-operative nausea | up to post-operative day 2 | Y/N |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-operative retching/vomiting | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | Y/N |
| Rescue antiemetic agent use | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | Number of administration |
| Post-operative pain score | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | Grading: 11-point numeric pain scale (0-10, 10 means the worst pain) |
| Rescue pain medication use | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | Number of administration |
| Incidence of post-operative nausea | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | Y/N |
| Severity of post-operative nausea | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | Grading: none, mild, moderate, severe |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic drug intervention | Intra-operative, day of surgery(during PACU stay) | Number of intervention |
| Intra-operative blood pressure | Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay) | Blood pressure (mmHg) |
| Intra-operative heart rate | Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay) | Heart rate (bpm) |
Countries
South Korea
Contacts
Primary ContactHyo-Seok Na
Outcome results
None listed