NCT01833819

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

10 months

First QC Date

March 12, 2013

Last Update Submit

November 12, 2013

Conditions

Chronic Cholecystitis

Keywords

Laparoscopic cholecystectomy,Total intravenous anesthesia,Propofol,Dexmedetomidine,Lidocaine,Remifentanil,Postoperative analgesic consumption,Postoperative nausea and vomiting

Outcome Measures

Primary Outcomes (1)

  • Postoperative fentanyl consumption

    Patients will use a Patient controlled analgesia (PCA) device for 6 hours after extubation

    6 hours after extubation

Secondary Outcomes (2)

  • Recovery time

    2 hours after cessation of anesthesia infusions

  • Postoperative nausea and vomiting

    Postoperative 24 hours

Study Arms (2)

Opiod-free group

OTHER

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

OTHER

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

Interventions

Dexmedetomidine and lidocaineDRUG
Opiod-free group
RemifentanilDRUG
Opioid-based group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists I-II patients
  • years

You may not qualify if:

  • American Society of Anesthesiologists III and above patients
  • BMI: 35 and above
  • Hepatic, renal or cardiac insufficiency
  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (1)

  • Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.

    PMID: 25925031DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

DexmedetomidineLidocaineRemifentanil

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPropionatesAcids, AcyclicCarboxylic AcidsPiperidines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

April 17, 2013

Study Start

June 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

TU(1)