Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy

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Brief Title

Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy

Official Title

Opioid-free Total Intravenous Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy; Comparison With Propofol, Remifentanil Infusions

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.
    

Detailed Description

      Patients are randomly allocated into two groups to have either 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 or opioid-based anesthesia (Group RF)
      with fentanyl, remifentanil (0.25μg/kg/min), and propofol infusions.

      Simple randomization was done using 80 opaque sealed envelopes, 40 for each group, indicating
      group assignment and describing the anesthetic protocol. Before anesthesia induction, an
      anesthesiologist will open the next envelope in the sequence to reveal the treatment
      allocation. This anesthesiologist will only prepare the study medications and will be
      involved in neither preoperative and postoperative data collection nor anesthesia management
      of the patients.

      The drugs will be delivered in 10 ml and 50 ml syringes labeled as "loading" or "infusion"
      respectively. To ensure proper blinding, the loading doses of drugs (dexmedetomidine and
      lidocaine in Group DL or fentanyl and normal saline in Group RF) will be calculated according
      to the patient's body weight and diluted to a 10 ml volume labeled as "loading-1" and
      "loading-2" in order of administration. The infusion drugs (dexmedetomidine and lidocaine in
      Group DL or remifentanil and normal saline in Group RF) will be prepared in 50 ml syringes
      and labeled as "infusion-1" and "infusion-2" respectively.

      At the preoperative holding area, patients will be instructed in the use of the verbal
      numerical rating scale (VNRS) and patient controlled analgesia (PCA) pump. Same
      anesthesiologist (MB) who is blinded to the study groups will perform the anesthesia
      management of all procedures.

      On arrival at the operating room, standard monitoring will be applied consisting of ECG,
      noninvasive blood pressure, pulse oximetry and bispectral index (BIS). After premedication
      with intravenous midazolam (0.03 mg/kg), baseline heart rate and mean arterial blood pressure
      (MAP) will be determined which are average of three consecutive measurements. Preoxygenation
      with 5 L/min of pure oxygen will be performed during administration of loading doses. Before
      induction, patients in Group DL received 0.6 μg/kg dexmedetomidine (loading-1) diluted to a
      total volume of 10 ml and infused in 10 minutes. To avoid bias, patients in Group RF will
      receive 2 μg/kg fentanyl in same fashion. At the induction, dexmedetomidine or remifentanil
      (1 μg/ml and 50 μg/ml respectively, infusion-1) infusions 0.3 ml/kg/h will be started and
      lidocaine 1.5 mg/kg (loading-2) in Group DL or normal saline in Group RF and propofol 1.5
      mg/kg will be administered. Lidocaine (20 mg/ml) or normal saline infusions 0.1 ml/kg/h and
      propofol infusion 10 mg/kg/h will be started immediately after loading doses. Vecuronium 0.1
      mg/kg i.v. will be given to facilitate tracheal intubation.

      The lungs will be mechanically ventilated with a mixture of oxygen in air (FiO2: 50%, tidal
      volume 7-10 ml/kg, respiratory rate 10-14/min) to obtain an end-tidal CO2 (EtCO2) value
      between 30-35 mmHg. Supplemental neuromuscular blockade will be achieved with vecuronium
      after assessment of neuromuscular function with train-of-four.

      Dexmedetomidine and lidocaine infusions in Group DL or remifentanil and normal saline
      infusions in Group RF will kept constant during surgery. Propofol infusion rate will be
      adjusted 3-12 mg/kg/h to maintain the MAP within ±20% of the baseline value, and to maintain
      a BIS reading below 50. The lidocaine or normal saline administration will be terminated
      after gallbladder extraction (or 10 min before the end of surgery). Dexmedetomidine or
      remifentanil and propofol administration will be terminated during skin closure.

      All patients in both groups will receive 8 mg dexamethasone and 50 mg dexketoprofen
      trometamol i.v. after anesthesia induction and 1 g paracetamol i.v. after gallbladder
      extraction. Laparoscopic portals will be infiltrated with 20 ml 0.5% bupivacaine including
      1/80.000 adrenaline before skin closure.

      Surgery: Surgeons who are experienced in laparoscopic cholecystectomy will performed the
      operations using standard 4-trocar technique. A blunt-tipped 12-mm trocar will be used to
      access the peritoneal cavity. Pneumoperitoneum will be achieved with carbon dioxide, and
      intra-abdominal pressure will be maintained at 12-14 mmHg throughout surgery. Three
      additional 5-mm ports will be introduced and patients will be positioned in 30 degrees
      anti-Trendelenburg position and be rotated toward the left side to facilitate exposure of the
      gallbladder. After endotracheal intubation a nasogastric tube will be inserted and stomach
      content will be aspirated. At the end of surgery, the inflated carbon dioxide will carefully
      be evacuated by manuel compression of the abdomen.

      A PCA pump will be ready to use immediately after extubation. The PCA pump will set to
      deliver fentanyl i.v. with a bolus dose of 20 μg, a lock-out of 5 min, without continuous
      infusion and dose limit for 6 hours after surgery. Trained nurses, blinded to treatment
      allocation and with no access to the intraoperative records, will perform all outcome
      assessments in the postanesthesia care unit (PACU) and surgical ward. Pain scores will be
      assessed using the 11-point VNRS (0 corresponding to no pain and 10 to the worst imaginable
      pain).

      Transition from PACU to surgical ward will be considered to be safe when patient will
      achieved a Modified Aldrete Score ≥ 9. Although laparoscopic cholecystectomy is established
      as a day-case procedure, our protocol is designed to admit all patients for 24 h to ensure
      adequate follow-up of patients and for proper data collection.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Postoperative fentanyl consumption

Secondary Outcome

 Recovery time

Condition

Chronic Cholecystitis

Intervention

Dexmedetomidine and lidocaine

Study Arms / Comparison Groups

 Opiod-free group
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

80

Start Date

June 2012

Completion Date

April 2013

Primary Completion Date

April 2013

Eligibility 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.)
      

Gender

All

Ages

20 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT01833819

Organization ID

B.30.2.BAV.0.05.05/346


Responsible Party

Sponsor

Study Sponsor

Bezmialem Vakif University


Study Sponsor

, , 


Verification Date

November 2013