Material and methods-
This randomized, double-blind study was conducted at Pandit Jawaharlal Nehru Govt Medical College and Hospital Chamba HP, India. The permission for the said work was taken from the local ethical committee of the same medical college. Each subject has given written consent and informed as per regulation of randomized, double-blind study. This study was conducted in a prospective, double-blind, and randomized fashion from July 2018 to Oct. 2018. Preoperative baseline values of heart rate and blood pressure and mandatory biochemical tests were recorded.
Forty subjects between 18-58 years were selected with ASA grade I-II undergoing elective laparoscopic cholecystectomy under general anesthesia (Kothari et al. 2000). We excluded subjects with any of the following symptoms like
- allergy to any drug,
- vomiting/retching/nausea / anti-emetic in 24h preceding administration of anesthesia,
- Subjects on chronic steroids, prokinetics.
- Anti-emetic/ antacids,
- Menstruating/ lactating or pregnant females
- History of alcohol or substance abuse,
- subjects with chronic diseases,
- QT prolongation on preoperative electrocardiography.
As per the regulations of the double-blind randomization technique, these subjects were equally divided into Group A (n=20) with Ondansetron 4.0 mg (fixed-dose), Group B(n=20) with Granisetron 0.75mg (fixed dose). Care was taken on the preparation of study drugs with the use of identical syringes (Mohammadi S t al 2015). All practitioners who are working for this research work were blinded to the allocation of Groups.
Anesthetics procedure (Erhen Y et al. 2008)
The patients were kept fasting after 10 PM a day before the surgery, and the baseline parameters were taken and recorded. Patients were anesthetized as per regulations under double-blind study. On arrival in Operation Theater, routine monitoring ECG plus p CO2 and baseline BP were recorded with the pulse oximeter.
The selected drugs were diluted with 10 ml of saline. The drug was given in period of 10min as per the randomized schedule. The patient was induced after preoxygenation for 3 min with inj. Propofol with 10mg per Kg body weight and incubation with an appropriate size tube with injection Vecuronium bromide 0.1 mg per Kg body weight and anesthesia were maintained with O2:N2O( 50%:50%), Isoflorane (0.8-1.0%).
Muscle relaxation was maintained with boluses of injection Vecuronium bromide, and intermittent positive pressure with end-tidal CO2 between 30-35mm Hg was maintained. A Ryles tube was placed for emptying airs and secretions from the stomach. An IV line was maintained with ringer lactate solution 2 ml per Kg body weight. During the surgery, strict watch was maintained in monitoring the intraabdominal pressure (IAP) between 10-12 mm of Hg. At the end of surgery, Ryle’s tube was removed after doing suction. Injection glycopyrrolate and neostigmine were given as reversal to remove the residual neuromuscular block, and extubation was done after adequate neuromuscular reversal. Injection diclofenac sodium 1mg/kg body weight was administered IV half an hour before the end of the surgery.
An IV line was maintained, and intravenous crystalloids were maintained 2ml/kg body after the surgery, and the patient was kept post-anesthesia care unit, and monitoring was continuously done.
Measurements
Pain intensity was assessed using VAS (Visual Analogue Score) with a four-point ordinal scale (0, none; 1, nausea; 2, retching; 3, vomiting). Any incidence of nausea, retching or vomiting, and use of any rescue medication during the 24 h at a time interval of 0,1,2,6,12,24 h was noted in PACU. Postoperative pain relief was provided with injection diclofenac sodium 1mg/kg intramuscularly 8h. If VAS score will >4, rescue analgesia was provided with injection paracetamol (1gm) intravenously ( Leksowski et al.).
For the study, all episodes of nausea, which were immediately followed by retching or vomiting, were taken as an episode of retching or vomiting, respectively. In case the patient exhibited all the three symptoms within 1-2 min, it was taken as one episode of vomiting. For statistical purposes, nausea (>10 min) without retching or vomiting was taken as an episode of nausea. Subjects who experience PONV despite receiving anti-emetic were classified as treatment failure. Side effects registered will headache, diarrhea, and dizziness in the initial 24h. The incidence of headache, dizziness, and skin flushing was checked at the same time for evaluating the adverse effects of 5-HT3 receptor antagonists.
Statistical analysis
Data were analyzed using Statistical Package for the Social Sciences ver. 23.0® software. The chi-squared test was performed among the groups. All values were expressed as the number of patients or mean ± standard deviation. A value of p < 0.05 was considered statistically significant.
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