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

Pain, Postoperative Clinical Trial

— GALOFF  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02953210
• Other study ID #: opioid free anesthesia
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 26, 2016
• Last updated: November 3, 2016
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: November 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Complication
• Hemodynamic Instability
• Ileus Paralytic
• Nausea
• Pain, Postoperative
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Brazil	Faculdade de Ciências Médicas da Santa Casa de São Paulo	Sao Paulo
Brazil	Faculdade de Ciências Médicas da Santa Casa de São Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Bisgaard T. Analgesic treatment after laparoscopic cholecystectomy: a critical assessment of the evidence. Anesthesiology. 2006 Apr;104(4):835-46. Review. — View 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( — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	will be asked pain at rest and movement and cough using the analog verbal scale of pain	60min after the surgery
Secondary	nausea/ vomiting	will be asked yes or not and how many times	12, 24 and 36 hours after surgery
Secondary	Paralytic ileus	will be access with ultrasound movement of intestine	12, 24 and 36 hours after surgery
Secondary	first analgesic rescue requirement	the first analgesic given at PACU when the patient asked for it	12 hours after the surgery
Secondary	pruritus	yes or no, mild, moderate to serve	12, 24 , 36 hours after surgery
Secondary	sedation	will be use the Ramasay scale	12, 24 and 26 hours after surgery
Secondary	time of discharge of PACU	time when the patient will transfer to ward after the surgery	12 hour after the surgery
Secondary	Hemodynamics effects	mean arterial pressure	intraoperative
Secondary	weight	measure in kilogram	Baseline
Secondary	height	measure in cm	Baseline
Secondary	gender	male or female	Baseline
Secondary	saturation of o2	oximetry	intraoperative
Secondary	ETCO2	capnography	intraoperative
Secondary	heart rate	heart rate	intraoperative
Secondary	pain	will be asked pain at rest and movement and cough using the analog verbal scale of pain	12, 24 and 36 hours after the procedure