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

NCT02953210 | Unknown Phase 4 DMC

• 1 other identifier: opioid free anesthesia
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  will be asked pain at rest and movement and cough using the analog verbal scale of pain

  60min after the surgery

Secondary Outcomes (14)

• nausea/ vomiting

  12, 24 and 36 hours after surgery

• Paralytic ileus

  12, 24 and 36 hours after surgery

• first analgesic rescue requirement

  12 hours after the surgery

• pruritus

  12, 24 , 36 hours after surgery

• sedation

  12, 24 and 26 hours after surgery

Study Arms (2)

GF general free

EXPERIMENTAL

pre induction midazolam 50ug.kg-1, clonidine 1ug.kg induction dexter ketamine 0.2mg.kg, lidocaine 1.5mg.kg, propofol 2mg.kg,rocuronium 0.6mg.kg maintenance isoflurane 1 CAM, lidocaine 2mg.kg.h

Drug: dexter ketamine; Drug: Lidocaine Hydrochloride; Drug: Clonidine Hydrochloride; Drug: Midazolam Hydrochloride; Drug: Isoflurane Volatile Liquid; Drug: Rocuronium Injectable Solution; Drug: Propofol 1 % Injectable Suspension; Drug: Dexamethasone-21-Sulfobenzoate, Sodium Salt; Drug: Ranitidine Hydrochloride; Drug: Ondansetron Hydrochloride; Drug: Ketorolac Injectable Solution; Drug: Bupivacaine Hydrochloride

GBal general balanced

ACTIVE COMPARATOR

pre induction with midazolam 50 ug.kg induction fentanyl 3ug.kg, propofol 2mg.kg, rocuronium 0.6mg.k maintenance isoflurane 1 CAM and fentanyl as needed

Drug: Fentanyl Hydrochloride; Drug: Midazolam Hydrochloride; Drug: Isoflurane Volatile Liquid; Drug: Rocuronium Injectable Solution; Drug: Propofol 1 % Injectable Suspension; Drug: Dexamethasone-21-Sulfobenzoate, Sodium Salt; Drug: Ranitidine Hydrochloride; Drug: Ondansetron Hydrochloride; Drug: Ketorolac Injectable Solution; Drug: Bupivacaine Hydrochloride

Interventions

dexter ketamine DRUG

multimodal anesthesia without opioids ketamine as induction drug

Also known as: ketamine plus

GF general free

Lidocaine Hydrochloride DRUG

continuous infusion intravenous

Also known as: xylocaine

GF general free

Fentanyl Hydrochloride DRUG

intravenous

Also known as: Fentanil

GBal general balanced

Clonidine Hydrochloride DRUG

clonidine intravenous pre induction

Also known as: Catapres

GF general free

Midazolam Hydrochloride DRUG

premedication

GBal general balanced; GF general free

Isoflurane Volatile Liquid DRUG

maintenance of general anesthesia

Also known as: isoflurane

GBal general balanced; GF general free

Rocuronium Injectable Solution DRUG

induction of general anesthesia

Also known as: rocuronium

GBal general balanced; GF general free

Propofol 1 % Injectable Suspension DRUG

induction of general anesthesia

Also known as: propofol

GBal general balanced; GF general free

Dexamethasone-21-Sulfobenzoate, Sodium Salt DRUG

at the end of the procedure 4mg IV

GBal general balanced; GF general free

Ranitidine Hydrochloride DRUG

at the end of the procedure

GBal general balanced; GF general free

Ondansetron Hydrochloride DRUG

at the end of the procedure

Also known as: ondasetron

GBal general balanced; GF general free

Ketorolac Injectable Solution DRUG

at the of the procedure

Also known as: keterolac

GBal general balanced; GF general free

Bupivacaine Hydrochloride DRUG

at the end of the procedure for infiltration of trocar wounds

Also known as: bupivacaine

GBal general balanced; GF general free

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Faculdade de Ciências Médicas da Santa Casa de São Paulo: collaborator

Study Sites (2)

Faculdade de Ciências Médicas da Santa Casa de São Paulo

São Paulo, São Paulo, 01221-020, Brazil

Location

Faculdade de Ciências Médicas da Santa Casa de São Paulo

São Paulo, São Paulo, 01333000, Brazil

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Nausea; Vomiting; Ileus

Interventions

Ketamine; Lidocaine; Fentanyl; Clonidine; Midazolam; Isoflurane; Rocuronium; Propofol; dexamethasone-21-sulfobenzoate; Ranitidine; Ondansetron; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazolines; Imidazoles; Azoles; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Methyl Ethers; Ethers; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Furans; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Study Officials

• marcelo v perez, PhD

  Faculdade De Ciencias Medicas da Santa Casa de Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 2, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 4, 2016

Record last verified: 2016-11

Locations

BR (2)