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IRCT2013022712123N2 IRCT 2013-09-07 Deputy of research, Shahroud University of Medical Sciences Cost-effectiveness analysis of intravenous propofol anesthesia versus inhalational Isoflurane anesthesia in patients undergo open surgery at Shahroud's Imam Hossein hospital. Comparative cost-effectiveness analysis of intravenous propofol anesthesia and inhalational isoflurane anesthesia in patients undergo open surgery with bispectral monitoring at Shahroud’s Imam Hossein hospital 2012-02-20 anticipated 100 Complete https://irct.ir/trial/12241 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Condition 1: Calculus of gallbladder with acute cholecystitis. Condition 2: Anesthesia for appendectomy. Condition 3: Ventral hernia without obstruction or gangrene. Condition 4: Unilateral or unspecified inguinal hernia, without obstruction or gangrene. Condition 5: Abnormal uterine and vaginal bleeding, unspecified. Condition 6: Fracture of neck of femur. Condition 7: Fracture of lower leg, including ankle. Condition 8: Fracture of upper limb, level unspecified. Intervention 1: In control group, premedication will be Fentanyl (1 µg/kg) and midazolam 0.05 mg/kg. Induction of anesthesia is intravenous propofol with dose of 1.5 mg/kg Maintenance of anesthesia will be performed with a consentration of 2% isoflurane (1.7 MAC) in combination with equal amount of N2O / O2 , Every 5 minutes isoflurane consentration will be adjusted according to depth of anesthesia. Intervention 2: In intervention group premedication is Fentanyl (1 µg/kg) and midazolam 0.05 mg/kg. Induction of anesthesia is intravenous propofol with dose of 1.5 mg/kg Maintenance of anesthesia intravenous propofol will be started at a rate of 140 µg/kg/hours in combination with equal amount of N2O / O2 , Every 5 minutes propofol infusion rate will be adjusted according to depth of anesthesia.

public Javad Nourian MD

Imam Hossein Hospital, operation room, End of Towhidi avenue

Shahroud Iran (Islamic Republic of) 3616911151 +98 27 3334 2001 javadnourian@shmu.ac.ir Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran scientific Javad Nourian MD

Imam Hossein Hospital, operation room, End of Ayatollah Towhidi avenue

Shahroud Iran (Islamic Republic of) 3616911151 +98 27 3334 2001 javadnourian@shmu.ac.ir Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran Iran (Islamic Republic of) Inclusion criteria:Man or woman with 18 to 50 years old;an anesthesia risk of 1 or 2 (According to American society of anesthesiologist's classification); orthopedic or reconstructive operations on extremities; hip and pelvic operations;Inguinal hernioraphy; abdominal hernioraphy; cholecystectomy; appendectomy. Exclusion criteria: Patients with a history of opiates or alcohol abuse; sedative and anticonvulsive therapy; anesthesia or surgical complications during operation 18 years 60 years Both K80.0 K35 K43.9 K40.9 N93.9 S72 S82 T10 Calculus of gallbladder with acute cholecystitis Acute appendicitis Ventral hernia Unilateral or unspecified inguinal hernia, without obstruction or gangrene Abnormal uterine and vaginal bleeding, unspecified Fracture of femur Fracture of lower leg, including ankle Fracture of upper limb, level unspecified Treatment - Drugs Treatment - Drugs In control group, premedication will be Fentanyl (1 µg/kg) and midazolam 0.05 mg/kg. Induction of anesthesia is intravenous propofol with dose of 1.5 mg/kg Maintenance of anesthesia will be performed with a consentration of 2% isoflurane (1.7 MAC) in combination with equal amount of N2O / O2 , Every 5 minutes isoflurane consentration will be adjusted according to depth of anesthesia. In intervention group premedication is Fentanyl (1 µg/kg) and midazolam 0.05 mg/kg. Induction of anesthesia is intravenous propofol with dose of 1.5 mg/kg Maintenance of anesthesia intravenous propofol will be started at a rate of 140 µg/kg/hours in combination with equal amount of N2O / O2 , Every 5 minutes propofol infusion rate will be adjusted according to depth of anesthesia. BIS (Depth of anesthesia). Timepoint: Every 5 minutes during operation. Method of measurement: By using Danmeter’s Cerebral State Monitor (Model CSM2) and record BIS index as an exact number from 0 to 100 every 5 minutes. Heart rate. Timepoint: before procedure and every 5 minutes during operation. Method of measurement: Novin saadat's cardiac monitoring and record as beat per minute. Systolic blood pressure. Timepoint: before procedure and every 5 minutes during operation. Method of measurement: Novin saadat's automatic Non invasive BP monitoring and record as mmHg. Pupil's reflex. Timepoint: Every 5 minutes during operation. Method of measurement: Clinical observation and chart as Yes or No. Pupil's size. Timepoint: every 5 minutes during procedure. Method of measurement: Clinical observation and chart as an exact number from 1 to 10 (milimeter). Sweating. Timepoint: Every 5 minutes during operation. Method of measurement: Clinical observation and chart as Yes or No. Postoperative agitation. Timepoint: Every 5 minutes during recovery. Method of measurement: Clinical observation and chart as Yes or No. Postoperative nausea and vomiting. Timepoint: Every 5 minutes during recovery. Method of measurement: Clinical observation and chart as Yes or No. Recovery time. Timepoint: Every 5 minutes during recovery. Method of measurement: The end of recovery will be determined by Modified Alderet scoring system (MASS). In this system, scoring 9 points in 5 variables of consciousness, circulation (systemic blood pressure), breathing, SPO2, and activity, each of 2 points, specifies the end of recovery. Postoperative pain. Timepoint: Every 5 minutes during recovery. Method of measurement: Clinical observation and chart as Yes or No. Anesthesia cost. Timepoint: Time of discharge. Method of measurement: Total drug's (Isoflurane or Propofol) cost in Rial. Deputy of research, Shahroud University of Medical Sciences Approved 2013-01-09 Ethics committee, Deputy of research, Shahroud University of Medical Sciences Ethics committee, Deputy of research, Shahroud University of Medical Sciences, 7th of Tir square, Shahroud, Iran. Postal code: 3614773955 Shahroud Iran (Islamic Republic of)