Remifentanil Without Muscle Relaxant for Thoracotomy
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|ClinicalTrials.gov Identifier: NCT02030808|
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : September 9, 2014
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 or disease||Intervention/treatment||Phase|
|Elective Open Thoracotomy||Drug: Muscle Relaxants (MR) group Drug: Non- Muscle Relaxants (NMR) group||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Target-Controlled Infusion of Remifentanil Without Muscle Relaxant Allows Acceptable Surgical Conditions During Thoracotomy|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||March 2014|
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
- Modified surgical rating scale [ Time Frame: for 3 hours after start of surgery ]
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.
- 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 ]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 ]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 ]Train-of-four ratio
- laryngoscopy conditions [ Time Frame: 1 min after laryngscopy ]laryngoscopy conditions
- intubating conditions [ Time Frame: 1 min after intubation ]intubating conditions
- Cost of medications [ Time Frame: after surgery ]cost of the used medications
- Need for vasoactive drugs [ Time Frame: for 3 hour during surgery ]use of ephedrine, and norepinephrine
- Recovery Times [ Time Frame: for 1 hours after surgery ]the times to spontaneous eye opening, obey verbal command, tracheal extubation and post-anesthesia care unit discharge
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): NCT02030808
|Al Khubar, Eastern, Saudi Arabia, 31952|
|Principal Investigator:||Mohamed R El Tahan, MD||Associate Professor at Anesthesiology Dept|
|Study Chair:||Mohamed A Regal, MD||Imam Abdulrahman Bin Faisal University|