]>
IRCT2012110711398N1 IRCT 2013-05-04 Research Deputy of Medicine Faculty, Tehran University of Medical Sciences Maintaining of remifentanil infusion until extubation Study of the effects of maintaining remifentanil infusion until tracheal extubation on the recovery profile and hemodynamic variables in the patients with elective craniotomy 2012-08-22 anticipated 62 Complete https://irct.ir/trial/11656 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. 2-3 Condition 1: Craniotomy of supratentorial lesion. Condition 2: Craniotomy of supratentorial lesion. Condition 3: Craniotomy of supratentorial lesion. Intervention 1: In the case group with last skin suture, infusion of propofol will be ceased but the infusion of remifentanil continued with the half dose of surgery time until response to verbal stimulation by patients. Intervention 2: In the control group, with the conclusion of surgery both drugs (propofol & remifentanil) will be discontinued and for blinding infusion of normal saline as placebo will starts.
public Amir Hossein Bagheri Aghdam MD.
Anesthesiolgy Department, Firouzgar Hospital, Beh-Afarin St. Karim Khan Av.
Tehran Iran (Islamic Republic of) +98 21 8214 1360 homopersicus@yahoo.com Tehran University of Medical Sciences scientific Mohammad Reza Ghodraty MD.
Department of Anesthesiology, Firouzgar Hospital, Beh-Afarin St. Karim Khan Av.
Tehran Iran (Islamic Republic of) +98 21 8894 6762 m-ghodrati@tums.ac.ir mrghodrati@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: patients who candidated to supratentorial craniotomy, Age from 18 to 65 years, ASA physical class I-II, preoperative GCS > 13 Eexclusion criteria: age> 65 <18 years, physical class ASA > II, GCS< 13, any allergy to the drugs of study, history of smoking, COPD, chronic cough, asthma, HTN, difficult airway and recent upper respiratory tract infections 18 years 65 years Both D33 C71 D43.0 Brain, supratentorial تومور بدخیم مغز Brain, supratentorial Prevention Placebo In the case group with last skin suture, infusion of propofol will be ceased but the infusion of remifentanil continued with the half dose of surgery time until response to verbal stimulation by patients. In the control group, with the conclusion of surgery both drugs (propofol & remifentanil) will be discontinued and for blinding infusion of normal saline as placebo will starts. Coughing & bucking intensity. Timepoint: during tracheal extubation. Method of measurement: Minogue Scale. Mean Arterial Pressure. Timepoint: Each 2 minutes from last skin suture or Mayfield opening until extubation and each 2 minutes after extubation until 10 minute later/each 5 minutes until 15 minute later in recovery room. Method of measurement: Automatic noninvasive sphigmomanumeter. Heart rate. Timepoint: Each 2 minutes from last skin suture or Mayfield opening until extubation and each 2 minutes after extubation until 10 minute later/each 5 minutes until 15 minute later in recovery room. Method of measurement: Pulse oximeter. Time interval to awakening after discontinuing of anesthesia drug. Timepoint: Verbal stimulation every min after discontinuing of propofol. Method of measurement: Time to opening of eye with stimulation by cornometer. Nausea & vomiting pervalance and intensity. Timepoint: Each 15 minutes until 1 hour in recovery room. Method of measurement: Four points score: 1 no sign, 2 mild, 3 moderate, 4 severe. Concsiousness level. Timepoint: Each 15 minutes until 1 hour in recovery room. Method of measurement: GCS (Glasco coma scale). Reoperation incidance rate. Timepoint: Till 48 houres after operation. Method of measurement: Sergeon's decision. Arrythemia incidance rate. Timepoint: After the last suture or Mayfield opening till O.R abondonment. Method of measurement: Contineous ECG monitoring. Research Deputy of Medicine Faculty, Tehran University of Medical Sciences Approved 2013-02-16 Tehran University Of Medical Sciences Ethics Committee Tehran University Of Medical Sciences, Ghods St. Keshavarz Blvd. tehran Iran (Islamic Republic of)