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Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 17, 2013
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bezmialem Vakif University
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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 ]

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

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833819

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01833819     History of Changes
Other Study ID Numbers: B.30.2.BAV.0.05.05/346
First Submitted: March 12, 2013
First Posted: April 17, 2013
Last Update Posted: November 13, 2013
Last Verified: November 2013

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

Additional relevant MeSH terms:
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia 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
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists