Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group OFA (Opioid-free anesthesia) | Experimental | Not using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (except a single dose of alfentanil for endotracheal intubation) |
|
| Group OUA (Opioid-using anesthesia) | Active Comparator | Using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (continuous infusion of remifentanil) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid-free anesthesia | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total incidence of post-operative nausea | Y/N | up to post-operative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-operative nausea | Y/N | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 |
| Severity of post-operative nausea | Grading: none, mild, moderate, severe |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Intra-operative heart rate |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyo-Seok Na | Contact | +821087012913 | hsknana@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Univ. Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
Not provided
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Opioid-using anesthesia | Procedure | 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 |
|
| day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 |
| 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 |
| Rescue antiemetic agent use | Number of administration | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 |
| 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 |
| Rescue pain medication use | Number of administration | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 |
Heart rate (bpm)
| Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay) |
| Hemodynamic drug intervention | Number of intervention | Intra-operative, day of surgery(during PACU stay) |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |