Laparoscopic Cholecystectomy, General Anesthesia, Cholelithiasis
Conditions
Interventions
This clinical trial will evaluate the postoperative recovery of women undergoing laparoscopic cholecystectomies under general anesthesia, comparing those who will receive general intravenous anesthesi
Drug
Procedure/surgery
Sponsors
Faculdade de Medicina de Jundiaí
Hospital Regional de Jundiaí
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Women; age between 18 and 65 years; ASA I or II physical condition; to undergo laparoscopic cholecystectomy performed electively and indicated due to cholelithiasis.
Exclusion criteria
Exclusion criteria: Patients who refuse to participate in the research; who are taking any sedative, opioid or sleep inducing drugs; Patients who refuse to participate in the research; who are taking any sedative, opioid or sleep inducing drugs; who have a history of allergy to any drug to be used in the study; carriers of severe obesity; pregnant or breastfeeding; carriers of pathologies that cause some cognitive deficit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We hope to evaluate the quality of postoperative recovery of patients submitted to elective laparoscopic cholecystectomies, comparing patients who will receive general intravenous anesthesia with controlled target infusion of propofol and remifentanil, and patients who will receive general anesthesia balanced with propofol, sevoflurane and remifentanil. The evaluation will be done by completing a questionnaire the day after surgery (Qor-40), which will be assigned a score ranging from 40 to 200 and will allow the quantification and comparison between anesthetic techniques regarding physical comfort, emotional state , physical independence, psychological support and pain. A score of less than 142 in the total Qor-40 sum will be considered poor recovery quality. We considered a difference in the QoR-40 score of 10 or more points as significant because a 10-point difference represented a 15% improvement in the quality of the postoperative recovery, as observed in a previous clinical trial, which based the calculation of the sample size. Once collected, quantitative data will be entered into a database in Excel® version 2016 and will be transferred and analyzed by SPSS software version 24. Categorical data will be compared using Fisher's exact test. Ordinal data and non-Gaussian continuous data (presented as median and interval) will be compared between the groups using the Wilcoxon Rank Sum test. Normally distributed data (presented as mean and SD) will be compared to each other using a two-sample independent t-test. A P value of 0.05 will be considered statistically significant. | — |
Secondary
| Measure | Time frame |
|---|---|
| We hope to assess whether any of the anesthetic techniques evaluated provided patients with less pain or less postoperative nausea and vomiting (PONV). This evaluation will be done by completing a questionnaire attached to QoR-40. | — |
Countries
Brazil
Contacts
Public ContactDaniel Carli
Faculdade de Medicina de Jundiaí
Outcome results
None listed