Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT01833819
First received: March 12, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

Opioids may attenuate postoperative hyperalgesia and postoperative nausea and vomiting. Our hypothesis is: opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy may achieve comparable hemodynamic stability during laparoscopy, with lower postoperative analgesic consumption and incidence of postoperative nausea and vomiting.


Condition Intervention Phase
Chronic Cholecystitis
Drug: Dexmedetomidine and lidocaine
Drug: Remifentanil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Opioid-free Total Intravenous Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy; Comparison With Propofol, Remifentanil Infusions

Resource links provided by NLM:


Further study details as provided by Bezmialem Vakif University:

Primary Outcome Measures:
  • Postoperative fentanyl consumption [ Time Frame: 6 hours after extubation ] [ Designated as safety issue: No ]
    Patients will use a Patient controlled analgesia (PCA) device for 6 hours after extubation


Secondary Outcome Measures:
  • Recovery time [ Time Frame: 2 hours after cessation of anesthesia infusions ] [ Designated as safety issue: Yes ]
    Extubation time after cessation of anesthesia infusions and discharge time from postanesthesia care unit (PACU) after extubation

  • Postoperative nausea and vomiting [ Time Frame: Postoperative 24 hours ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Opiod-free group
Opioid-free anesthesia (Group DL) with dexmedetomidine (0.6 mg/kg loading, 0.3 mg/kg/h infusion), lidocaine (1.5 mg/kg loading, 2 mg/kg/h infusion), and propofol infusions (3-12 mg/kg/h).
Drug: Dexmedetomidine and lidocaine
Opioid-based group
Opioid-based anesthesia (Group RF) with single dose fentanyl (2μg/kg), remifentanil (0.25μg/kg/min), and propofol infusions (3-12 mg/kg/h).
Drug: Remifentanil

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists I-II patients
  • 20-60 years

Exclusion Criteria:

  • American Society of Anesthesiologists III and above patients
  • BMI: 35 and above
  • Hepatic, renal or cardiac insufficiency
  • 2 degree Heart block and above
  • Diabetes
  • Psychiatric disease
  • History of chronic pain
  • Alcohol or drug abuse
  • Allergy to any of a drug in the study groups
  • Pregnant, breast-feeding or menstruating women
  • Inability to use a patient-controlled analgesia device
  • Any analgesic or antiemetic use in last 24 hours before anesthesia induction
  • Any surgical complication that may affect the outcomes of the study (open surgery etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833819

Locations
Turkey
Bezmialem Vakif University Faculty of Medicine
Istanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
  More Information

No publications provided

Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01833819     History of Changes
Other Study ID Numbers: B.30.2.BAV.0.05.05/346
Study First Received: March 12, 2013
Last Updated: November 12, 2013
Health Authority: Turkey: Ministry of Health of Turkey General Directorate of Pharmaceuticals and Pharmacy

Keywords provided by Bezmialem Vakif University:
Laparoscopic cholecystectomy,
Total intravenous anesthesia,
Propofol,
Dexmedetomidine,
Lidocaine,
Remifentanil,
Postoperative analgesic consumption,
Postoperative nausea and vomiting

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Anesthetics
Lidocaine
Propofol
Remifentanil
Dexmedetomidine
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on August 21, 2014