Post-operative Nausea Vomiting in Laparoscopic Cholecystectomy
Post-operative Nausea Vomiting in Laparoscopic Cholecystectomy
-  To study the efficacy and side effects of ondansetron with dexamethasone in patients
 undergoing standard laparoscopic cholecystectomy (control group).

 -  To study the efficacy and side effects of ramosetron in patients undergoing standard
 laparoscopic cholecystectomy (study group).

 -  To compare the efficacy and side effects of ondansetron with dexamethasone and
 ramosetron in patients undergoing standard laparoscopic cholecystectomy
100 ASA Grade I/II young female patients of 20-40 years undergoing elective laparoscopic
 cholecystectomy will be equally divided into 2 groups (50 each): control group(Group 'O') and
 study group (Group 'R') using a computer generated sealed envelopes.

 Control group patients will receive ondansetron with dexamethasone and the study group
 patients will receive ramosetron. Based on the previous studies advocating use of the minimum
 recommended doses, ramosetron in a dose of 0.3 mg and ondansetron in a dose of 4 mg and
 dexamethasone in a dose of 8mg will be administered for prevention of PONV in the present
 study. Medications will be prepared by a blinded paramedic not involved in the study in
 identical 5-ml syringes and will be administered according to the randomization list.
 Patients will be given tablet alprazolam(0.25 mg) orally on the night before surgery and
 advised nil per orally from midnight.

 Inside operation theatre, patient NPO status and identity will be reassured. Intravenous line
 will be secured using 18 G IV cannula and intravenous fluid will be started. Standard
 non-invasive monitoring will be established intraoperatively using NIBP, HR, ECG, RR, SpO2
 and will be continuous postoperatively. Patients will be premedicated with injection
 Glycopyrrolate (0.004mg/kg), injection Ranitidine (1mg/kg), injection metoclopramide
 (0.15mg/kg), injection butorphanol (0.04mg/kg). Patients will be induced with injection
 propofol 2 mg/ kg mixed with xylocard 2%(10mg of xylocard per 10ml propofol) and injection
 Succinylcholine 1.5 mg/kg and endotracheal intubation will be done. A nasogastric tube will
 be inserted after securing the endotracheal tube in place and confirming it with ETCO2
 monitoring. Anesthesia will be maintained with nitrous oxide and halothane (0.4-1%) in
 oxygen. Intra-operative muscle relaxation was maintained with injection vecuronium.

 At the end of the surgery, injection diclofenac 75 mg IM will be given before the reversal of
 neuromuscular blockade to pre-empt the post-operative pain and will be advised as IM
 injection twice a day for post operative analgesia. Additional post-operative analgesia will
 be provided with injection tramadol 2 mg/ kg slowly as and when required intravenously.
 Nasogastric suction will be done to remove any residual gastric contents. Residual effect of
 muscle relaxant will be reversed with injection neostigmine (0.04 mg/ kg) and injection
 glycopyrrolate (0.2mg for each 1.0 mg 0f neostigmine). Ondansetron (4 mg) with dexamethasone
 (8mg) or ramosetron (0.3 mg) will be administered intravenously before shifting of the
 patient from the operation theater to the post-anesthesia care unit (PACU) according to the
 group allocation. All port sites will be infiltrated with inj bupivacaine (0.25%).

 In the post-operative period, patients will be monitored for nausea, vomiting, pain, vital
 signs, adverse effects and post-anesthetic discharge score for 48 h (every 4 hourly in first
 24 hours and every 6 hourly in next 24 hours) and this will be recorded by an independent
 observer (usually a Resident Officer) who will be blinded to the study. Injection
 metoclopramide (10 mg I.V.) will be administered as an additional rescue antiemetic in
 patients with two or more than two episodes of vomiting and/or significant nausea at any time
 within 48 h of operation. Exact timing of the administration of the rescue antiemetic will be
 recorded.

 Adverse effects of Ramosetron will also be monitored like- Abdominal pain, Hard stools,
 Constipation, bloating, Hepatic dysfunction, reflux esophagitis, decrease in platelet count,
 Duodenal ulcer, Palpitation.

 Nausea is defined as a subjectively unpleasant sensation associated with awareness of the
 urge to vomit whereas retching is defined as the labored spasmodic, rhythmic contraction of
 the abdominal muscles without expulsion of gastric contents, and vomiting is defined as the
 forceful expulsion of gastric contents from the mouth. Nausea will be measured using an 10
 point numerical visual analogue scale with 0 = no nausea and 10 = nausea as bad as can be. A
 score of > 5 will be considered severe, 5 = moderate and < 5 = minimal. The moderate and
 severe nausea will be considered as major nausea. During the period of monitoring, the
 -vomiting/retching episodes of >2 will be considered severe, 2 as moderate, and <2 as mild.
 Vomiting occurring up to 24 h after surgery will be taken as early vomiting whereas delayed
 vomiting consist of vomiting occurring during 24-48 h after surgery. A complete response will
 be defined as the absence of PONV.
Inclusion Criteria:

 -  Female patients of age group 20 - 40years undergoing elective laparoscopic
 cholecystectomy

 -  ASA Physical Status- I & II

 Exclusion Criteria:

 -  • Negative consent

 -  History of motion sickness

 -  Pregnancy

 -  Menstruating females

 -  Antiemetic taken within 24 hours before surgery or any long term medication

 -  History of any systemic diseases, cardio- respiratory, hepato-renal,
 neurological, endocrinal disorders, hematological disorders, drug or alcohol
 addiction, psychiatric diseases, study drug sensitivity, etc