This single-blind clinical trial study was performed between September 2015 and March 2016 in Imam Reza hospital, AJA University of Medical Sciences, Tehran, Iran. The project was registered in Iranian randomized clinical trial site (registration No. IRCT2015070723098N1). The study was conducted in military patients at a military hospital. After obtaining approval from the ethics committee of the university, 88 patients, who were candidates for lumbar vertebral laminectomy surgery due to intervertebral disc herniation, were recruited. All patients had American Society of Anesthesiology physical status 1 and 2. No age or sex restrictions were applied. Exclusion criteria were as follows: known allergy to anesthetic drugs propofol or isoflurane, hypersensitivity to egg and soybean products, known or suspected susceptibility to malignant hyperthermia, renal impairment, and hyperkalemia, coagulopathy disorders, refused patients. After taking written informed consent, the patients were randomly allocated to one of the two pathways of anesthesia methods either with intravenous infusion of propofol (PRO) or with inhalational isoflurane (ISO). Randomization was performed by selecting an unmarked envelope by patients (simple randomization) just before induction, which contained ISO or PRO cards. All surgical procedures and anesthesia were performed by the same neurosurgery team and anesthesiology specialist. The surgeon and examiner were unaware of the allocation of patients to ISO or PRO groups and the same examiner was used for all subjects. The propofol infusion pump was also set to all patients in either ISO or PRO groups but without the infusion running in the ISO group in order to conceal the method of anesthesia from surgical team.
Patients were monitored for heart rate, brachial systolic/diastolic blood pressure (non-invasive), Electrocardiography, pulse oximetry, end-tidal CO2, and urine output.
All patients were primarily ventilated with 100% oxygen. Anesthesia was induced by intravenous infusion of thiopental 5 - 7 mg kg-1 in the ISO group and propofol 2 mg kg-1 in the PRO group. Thereafter, Atracurium at a dose of 0.6 mg kg-1 was administered for muscular paralysis. Orotracheal intubation was performed and lungs were mechanically ventilated with 50% N2O in Oxygen to maintain the end-tidal CO2 concentration of 35 - 40 mmHg. The patients were turned to the prone position and surgical field prepared. Anesthesia was maintained in the ISO group by isoflurane inhalation at a dose of 1 - 1.5 maximum alveolar concentration (MAC) in 50% O2-N2O mixture. PRO patients received a continuous infusion of propofol 150 μg kg-1 min-1 for maintenance of anesthesia.
Demographic data were recorded before the anesthesia induction. The duration of anesthesia was recorded from the induction up to the patients’ eye-opening. The heart rate, systolic, and diastolic blood pressure were measured before the induction of anesthesia and in every 15-minutes intervals during the maintenance of anesthesia.
We assessed the qualitative state of surgical field bleeding during the operation using a 0 - 5 grading scale previously described as Boezaart criteria (
Table 1) for endoscopic sinus surgeries (
8).
| Bleeding | |
|---|
| 0 No bleeding | (Cadaveric conditions) |
| 1 Slight bleeding | No suctioning required |
| 2 Slight bleeding | occasional suctioning required |
| 3 Slight bleeding | Frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed. |
| 4 Moderate bleeding | Frequent suctioning required. Bleeding threatens surgical field directly after suction is removed. |
| 5 Severe bleeding | Constant suctioning required. Bleeding appears faster than it can be removed by suction; surgical field severely threatened and surgery usually not possible. |
The overall surgeon satisfaction with anesthesia and surgical condition was assessed through a 1 - 5 scored scale in which, score 1 represented the lowest satisfaction and 5 indicated the complete satisfaction of the surgeon. This parameter was inquired from the surgeon 30 minutes after the end of the operation.
Bleeding volume was calculated as the total fluid volume in suction bottle minus the amount of irrigation solution used during the surgery added to the blood volume absorbed to gauzes. Wet gauzes were counted after the operation and each was considered to contain nearly 30 milliliters of blood. We assumed each long gauze to hold about 50 milliliters of blood.
2.1. Statistical Analyses
We used SPSS-20 software for statistical analysis of the parameters.The Chi-squared test was used to compare male/female ratio in the two groups of patients. The Independent T-test was used for analysis of age, heart rate, and mean bleeding volume between the two groups, and systolic and diastolic blood pressure before the induction and during the maintenance of anesthesia. The analysis of variance (ANOVA) was performed for comparing heart rate and blood pressure in time intervals after anesthesia induction. Boezaart grade and surgeon satisfaction scores with nonparametric distribution were analyzed using Mann-Whitney U test. P value < 0.05 was considered for statistical significance of correlations.