Postoperative nausea and vomiting
Conditions
Interventions
All patients, before inclusion in the study, signed the Informed Consent Form and were then randomly assigned, using specific software, to two groups: experimental (Group M – methadone) and control (G
s admission to the operating room. Participant data were recorded in separate tables: one for admission to the operating room and another for collecting intra- and postoperative information, with subs
s group to avoid bias in data collection and interpretation. Syringes containing methadone (Group M) or fentanyl (Group F) were prepared by an anesthesiologist not directly involved in the research. T
100 kg and 3 g in >
100 kg)
in case of allergy, clindamycin would be used. Anesthetic induction was performed with propofol (2 mg/kg) and rocuronium (
Sponsors
Centro Uiversitário Una
Complexo Hospitalar Santa Genoveva
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients will be included if they: have signed an informed consent form; belong to American Society of Anesthesiologists (ASA) physical status I or II; have a surgical indication for laparoscopic cholecystectomy; have no chronic opioid use; have no severe psychiatric disorders or cognitive dysfunction; and have a body mass index (BMI) < 35 kg/m²
Exclusion criteria
Exclusion criteria: Patients will be excluded if they have: a known allergy to fentanyl, methadone, or any other drug included in the study; belong to American Society of Anesthesiologists (ASA) physical status greater than or equal to III; are using tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs); have severe liver or kidney disease; have a diagnosis of untreated cardiac arrhythmias or long QT syndrome; are under 18 years of age or over 65 years of age; have severe sleep apnea diagnosed by polysomnography.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will consist of a composite outcome of the incidence of any episode of moderate/severe pain and any episode of postoperative nausea and vomiting during hospitalization. Considering a moderate/severe pain incidence of 45% and a postoperative nausea and vomiting rate of 25% in laparoscopic cholecystectomy surgeries found in previous studies, it is expected that the use of methadone will be able to reduce the primary composite outcome measure by 50% (70% to 35%). For the primary outcome assessment, moderate to severe pain will be defined as any pain intensity rated by the patient as 4 or higher on the verbal numerical rating scale for pain at any time point during the patient assessment. The incidence of postoperative nausea and vomiting will be documented dichotomously (yes/no) at any time point during the patient assessment. Patients will be assessed within the first hour after surgery (15, 30, 45, and 60 minutes), and 6 and 12 hours after surgery in the groups undergoing induction with methadone or fentanyl | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of opioid-related adverse events;Cumulative consumption of rescue opioids in the postoperative period, expressed in milligrams of intravenous morphine equivalent (MME), during the hospitalization period.;Total cumulative dose of opioids administered during hospitalization, expressed in milligrams of intravenous morphine equivalent (MME). | — |
Countries
Brazil
Contacts
Public ContactJoão Paulo Jordão Pontes
Complexo Hospitalar Santa Genoveva
Outcome results
None listed