NCT02030808|CompletedPhase 2DMC
Remifentanil Without Muscle Relaxant for Thoracotomy
Target-Controlled Infusion of Remifentanil Without Muscle Relaxant Allows Acceptable Surgical Conditions During Thoracotomy
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Sponsor study identifier
interventional
66
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Actual (reported)Study Completion
March 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
January 7, 2014
Actual (reported)January 9, 2014
Actual (reported)February 2014
Actual (reported)March 2014
Actual (reported)Modified surgical rating scale
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.
for 3 hours after start of surgery
heart rate
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
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
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
laryngoscopy conditions
1 min after laryngscopy
intubating conditions
1 min after intubation
Cisatracurium will be administered
No cisatracurium will be administered
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
No cisatracurium® (Nimbex) will be administered
Dammam University
Khobar, Eastern Province, 31952, Saudi Arabia
Mohamed R El Tahan, MD
Associate Professor at Anesthesiology Dept
Mohamed A Regal, MD
Imam Abdulrahman Bin Faisal University
66 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2014
First Posted
January 9, 2014
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
February 2014
Actual (reported)Study Completion
March 2014
Actual (reported)Last Updated
September 9, 2014
Record last verified: 2014-09
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Source: ClinicalTrials.gov.
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