Laparoscopic Cholecystectomy: General Anesthesia With Opioid Versus General Opioid Free Anesthesia

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.

• dexter ketamine (Drug), also known as ketamine plus: multimodal anesthesia without opioids ketamine as induction drug
• Lidocaine Hydrochloride (Drug), also known as xylocaine: continuous infusion intravenous
• Fentanyl Hydrochloride (Drug), also known as Fentanil: intravenous
• Clonidine Hydrochloride (Drug), also known as Catapres: clonidine intravenous pre induction
• Midazolam Hydrochloride (Drug): premedication
• Isoflurane Volatile Liquid (Drug), also known as isoflurane: maintenance of general anesthesia
• Rocuronium Injectable Solution (Drug), also known as rocuronium: induction of general anesthesia
• Propofol 1 % Injectable Suspension (Drug), also known as propofol: induction of general anesthesia
• Dexamethasone-21-Sulfobenzoate, Sodium Salt (Drug): at the end of the procedure 4mg IV
• Ranitidine Hydrochloride (Drug): at the end of the procedure
• Ondansetron Hydrochloride (Drug), also known as ondasetron: at the end of the procedure
• Ketorolac Injectable Solution (Drug), also known as keterolac: at the of the procedure
• Bupivacaine Hydrochloride (Drug), also known as bupivacaine: at the end of the procedure for infiltration of trocar wounds

Primary outcomes

• postoperative pain [60min after the surgery]: will be asked pain at rest and movement and cough using the analog verbal scale of pain

Secondary outcomes

• nausea/ vomiting [12, 24 and 36 hours after surgery]: will be asked yes or not and how many times
• Paralytic ileus [12, 24 and 36 hours after surgery]: will be access with ultrasound movement of intestine
• first analgesic rescue requirement [12 hours after the surgery]: the first analgesic given at PACU when the patient asked for it
• pruritus [12, 24 , 36 hours after surgery]: yes or no, mild, moderate to serve
• sedation [12, 24 and 26 hours after surgery]: will be use the Ramasay scale
• time of discharge of PACU [12 hour after the surgery]: time when the patient will transfer to ward after the surgery
• Hemodynamics effects [intraoperative]: mean arterial pressure
• weight [Baseline]: measure in kilogram
• height [Baseline]: measure in cm
• gender [Baseline]: male or female
• saturation of o2 [intraoperative]: oximetry
• ETCO2 [intraoperative]: capnography
• heart rate [intraoperative]: heart rate
• pain [12, 24 and 36 hours after the procedure]: will be asked pain at rest and movement and cough using the analog verbal scale of pain

Sex: All, ages: 30 Years to 70 Years

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

• 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. PMID 16571981
• 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. PMID 22584558
• Results publication: 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. PMID 17959952

• marcelo v perez, PhD, Principal investigator, Faculdade De Ciencias Medicas da Santa Casa de Sao Paulo