Remifentanil Without Muscle Relaxant for Thoracotomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dammam University
ClinicalTrials.gov Identifier:
NCT02030808
First received: January 7, 2014
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

Although the administration of muscle relaxation is essential standard of care for thoracic procedures, it could cause long-reversal times and postoperative residual curarization (PORC) increasing length of post-anesthesia care unit (PACU) stay and hospital costs. Sugammadex offers new perspectives to reduce the incidence of PORC. Unfortunately it is not available in many countries because of its significantly high cost. We hypothesized that the use of target-controlled remifentanil infusion (TCI) with the non-muscle relaxant (NMR) would be associated with comparable surgical conditions and reduced total costs compared with the use of neuromuscular blockers during thoracotomy.

After ethical approval, 66 patients scheduled for elective thoracotomy under sevoflurane anesthesia with TCI remifentanil will be included in this prospective, randomized, single-blind, controlled study.

Patients will be randomly assigned to receive cisatracurium or saline (n = 33 for each group) throughout the procedure. Laryngoscopy and intubating conditions, intraoperative modified thoracic surgery rating scale (Table below), incidence of light anesthesia, and use of vasopressors and anesthetics, clinical recovery, incidence of PORC, PACU and hospital stays, and total costs will be recorded.


Condition Intervention Phase
Elective Open Thoracotomy
Drug: Muscle Relaxants (MR) group
Drug: Non- Muscle Relaxants (NMR) group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Target-Controlled Infusion of Remifentanil Without Muscle Relaxant Allows Acceptable Surgical Conditions During Thoracotomy

Resource links provided by NLM:


Further study details as provided by Dammam University:

Primary Outcome Measures:
  • Modified surgical rating scale [ Time Frame: for 3 hours after start of surgery ] [ Designated as safety issue: Yes ]

    A four-point ordinal scale adopted from the surgical rating scale of Martini et al.,ranging from 1 (extremely poor conditions) to 4 (optimal conditions).

    Extremely poor (Score 1) indicates that the surgeon is unable to work because of coughing, bucking, diaphragmatic contractions or movements, or the inability to spread or approximate the ribs during chest opening and closure, respectively, because of inadequate muscle relaxation;

    poor (Score 2) indicates that there is a visible field, but the surgeon is severely hampered by continuous muscle contractions, spontaneous movements of the surgical lung, or both that could cause hazard of tissue damage;

    good (Score 3) indicates that there is an acceptable field with sporadic muscle contractions causing some interference with the surgeon's work;

    excellent (Score 4) indicates a wide working field without any lung movement or muscle contractions.



Secondary Outcome Measures:
  • heart rate [ Time Frame: 5 min after induction of anesthesia, 1 min after chest opening, 30 min after start of surgery, 60 min after start of surgery, 90 min after start of surgery, 120 min after start of surgery, 1 min after start of chest closure, 5 min after extubation ] [ Designated as safety issue: Yes ]
    heart rate

  • Mean blood pressure [ Time Frame: 5 min after induction of anesthesia, 1 min after chest opening, 30 min after start of surgery, 60 min after start of surgery, 90 min after start of surgery, 120 min after start of surgery, 1 min after start of chest closure, 5 min after extubation ] [ Designated as safety issue: Yes ]
    Mean blood pressure

  • Train-of-four ratio [ Time Frame: 5 min after induction of anesthesia, 1 min after chest opening, 30 min after start of surgery, 60 min after start of surgery, 90 min after start of surgery, 120 min after start of surgery, 1 min after start of chest closure, 5 min after extubation ] [ Designated as safety issue: No ]
    Train-of-four ratio

  • laryngoscopy conditions [ Time Frame: 1 min after laryngscopy ] [ Designated as safety issue: No ]
    laryngoscopy conditions

  • intubating conditions [ Time Frame: 1 min after intubation ] [ Designated as safety issue: Yes ]
    intubating conditions

  • Cost of medications [ Time Frame: after surgery ] [ Designated as safety issue: No ]
    cost of the used medications

  • Need for vasoactive drugs [ Time Frame: for 3 hour during surgery ] [ Designated as safety issue: Yes ]
    use of ephedrine, and norepinephrine

  • Recovery Times [ Time Frame: for 1 hours after surgery ] [ Designated as safety issue: Yes ]
    the times to spontaneous eye opening, obey verbal command, tracheal extubation and post-anesthesia care unit discharge


Enrollment: 66
Study Start Date: January 2014
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Muscle Relaxants (MR) group
Cisatracurium will be administered
Drug: Muscle Relaxants (MR) group
patients received 0.2 mL/kg cisatracurium® (Nimbex) 0.2%, and a left-sided endobronchial double-lumen tube was placed when the TOF revealed one or two twitches
Active Comparator: Non- Muscle Relaxants (NMR) group
No cisatracurium will be administered
Drug: Non- Muscle Relaxants (NMR) group
No cisatracurium® (Nimbex) will be administered

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical class (II-III)
  • elective open thoracotomy

Exclusion Criteria:

  • New York Heart Association class> II)
  • Forced vital capacity < 50% of the predicted values
  • Forced expiratory volume in 1 second < 50% of the predicted values
  • Hepatic diseases
  • Renal diseases.
  • Reactive airways.
  • Neuromuscular diseases.
  • Asthma
  • Pregnancy
  • Increased risk of regurgitation
  • Anticipated difficult intubation
  • Body mass index >35 kg/m2
  • Electrolytes abnormalities
  • Acid base abnormalities
  • Repeat surgery
  • history of head and neck surgery
  • Preoperative circulatory support
  • Preoperative ventilatory support
  • Medications affecting the neuromuscular junctions
  • Family history of malignant hyperthermia
  • Allergy to any of the study drugs
  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: NCT02030808

Locations
Saudi Arabia
Dammam University
Al Khubar, Eastern, Saudi Arabia, 31952
Sponsors and Collaborators
Dammam University
Investigators
Principal Investigator: Mohamed R El Tahan, MD Associate Professor at Anesthesiology Dept
Study Chair: Mohamed A Regal, MD University of Dammam
  More Information

No publications provided

Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT02030808     History of Changes
Other Study ID Numbers: Anesth-Dec13(2)
Study First Received: January 7, 2014
Last Updated: September 8, 2014
Health Authority: Saudi Arabia: Ministry of Higher Education

Keywords provided by Dammam University:
Thoracic surgery
non-muscle relaxant
target-controlled infusion
remifentanil
surgical conditions

Additional relevant MeSH terms:
Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Remifentanil
Cisatracurium
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Neuromuscular Blocking Agents
Neuromuscular Agents

ClinicalTrials.gov processed this record on September 18, 2014