Clinical trial NCT02953210: Laparoscopic Cholecystectomy: General Anesthesia With Opioid Versus General Opioid Free Anesthesia
Official title: Comparative Randomized Controlled Trial Study of General Balanced Anesthesia Based on Opioid and Opioid Sparing Balanced Anesthesia for Cholecystectomy Surgery Via Laparoscopy: Intraoperative and Postoperative Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Anesthesia Complication
Nausea
Vomiting
Ileus Paralytic
Hemodynamic Instability
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Faculdade de Ciências Médicas da Santa Casa de São Paulo
First posted: 2016-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of opioid during surgery can cause side effects and may delay hospital discharge. Some studies have shown balanced sparing opioid anesthesia can optimize the side effects and and the time of discharge. In this compared controlled randomized study the aim is to evaluate the intraoperative and postoperative pain, hemodynamic effects, nausea/vomiting, postoperative ileus, sedation, urinary retention, time of discharge PACU Post anesthesia care unit and hospital.

Detailed description: Patients under laparoscopic cholecystectomy has moderate to severe pain. This study will compare intraoperative hemodynamic parameters under two techniques of general anesthesia: The primary outcome pain was used for planning the sample size of participants and considered a variation of 3 points on VAS (Visual analogic scale of pain). The secondaries outcomes nausea/vomiting, sedation, ileus paralytics, urinary retention, time of discharge (PACU) and hospital stay, and patient satisfaction will be recorded and analyzed.

the patients will be allocated from randomized program in one of the two arms.

1. Based opioid balanced anesthesia propofol, fentanyl, rocuronium and isoflurane
2. Opioid sparing balance anesthesia with propofol, dexter- ketamine, clonidine, midazolan,isoflurane and lidocaine.

At the end of procedure both groups will receive dexamethasone, ranitidine

, ondansetron, keterolac IV and local infiltration of bupivacaine on trocar wounds as multimodal analgesia.

General anesthesia opioid free seems to have less side effects than the general anesthesia based on opioid this study will compare it.

Eligibility criteria: Inclusion Criteria:

* Patient under Laparoscopic cholecystectomy routine American Society of Anesthesiology ASA I or II

Exclusion Criteria:

* chronic use of opioids
* Body mass index (BMI) \> 35 Kg.m-2
* Chronic heart failure, renal and hepatic failure
* illicit drugs users
* cognitive impairments

Primary outcomes:
measure: postoperative pain
timeFrame: 60min after the surgery
Secondary outcomes:
measure: nausea/ vomiting
timeFrame: 12, 24 and 36 hours after surgery
measure: Paralytic ileus
timeFrame: 12, 24 and 36 hours after surgery
measure: first analgesic rescue requirement
timeFrame: 12 hours after the surgery
measure: pruritus
timeFrame: 12, 24 , 36 hours after surgery
measure: sedation
timeFrame: 12, 24 and 26 hours after surgery
measure: time of discharge of PACU
timeFrame: 12 hour after the surgery
measure: Hemodynamics effects
timeFrame: intraoperative
measure: weight
timeFrame: Baseline
measure: height
timeFrame: Baseline
measure: gender
timeFrame: Baseline
measure: saturation of o2
timeFrame: intraoperative
measure: ETCO2
timeFrame: intraoperative
measure: heart rate
timeFrame: intraoperative
measure: pain
timeFrame: 12, 24 and 36 hours after the procedure
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Faculdade de Ciências Médicas da Santa Casa de São Paulo
city: Sao Paulo
country: Brazil
facility: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Study officials:
affiliation: Faculdade De Ciencias Medicas da Santa Casa de Sao Paulo
name: marcelo v perez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bisgaard T. Analgesic treatment after laparoscopic cholecystectomy: a critical assessment of the evidence. Anesthesiology. 2006 Apr;104(4):835-46. doi: 10.1097/00000542-200604000-00030.
citation: De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ. Systemic lidocaine to improve postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg. 2012 Aug;115(2):262-7. doi: 10.1213/ANE.0b013e318257a380. Epub 2012 May 14.
citation: Collard V, Mistraletti G, Taqi A, Asenjo JF, Feldman LS, Fried GM, Carli F. Intraoperative esmolol infusion in the absence of opioids spares postoperative fentanyl in patients undergoing ambulatory laparoscopic cholecystectomy. Anesth Analg. 2007 Nov;105(5):1255-62, table of contents. doi: 10.1213/01.ane.0000282822.07437.02.