Effect of single dose of IV dexamethasone on the incidence of post-operative sore-throat  nausea, vomiting and pain in patients undergoing breast surgeries- A Randomized control trial

Background and Aims:

Breast surgeries are commonly performed under general anesthesia with laryngeal mask airway. Post operatively sore-throat (POST), postoperative nausea, vomiting (PONV) and pain are the main complaints following breast surgeries. POST can be associated with hoarseness of voice and cough. Even though these symptoms resolve spontaneously, prophylactic management of POST, nausea and vomiting are recommended to improve the quality of post-anaesthesia care.  Various drugs like ketamine, lidocaine,  magnesium sulphate etc are administered to reduce the incidence of sore-throat. Ondansetron is usually administered to prevent PONV. Dexamethasone is a steroid antiemetic used even in cancer patients. Dexamethasone is also known to reduce POST and reduce postoperative opioid requirement. Hence this study is performed to assess the effectiveness of single dose of IV dexamethasone given pre operatively to reduce the incidence of   POST , PONV and postoperative opioid consumption.Primary objective is to assess the reduction in incidence and severity of postoperative sore throat in patients undergoing breast surgery under general  anaesthesia with laryngeal mask airway in patients. Secondary objectives include reduction in incidence of postoperative hoarseness of voice,cough,PONV,pain score and postop analgesic requirement.

Methods

This prospective, randomised, double blinded study will be conducted after obtaining approval from hospital ethical committee, clinical trial registry of India (CTRI)  and informed written consent from patients.  Patients aged 18–60 years, of the American Society of Anaesthesiologists (ASA) physical status 1–2, undergoing breast surgeries lasting 2-3h under general anaesthesia with laryngeal mask airway will be included in this study. Patients with anticipated difficult airway, history of allergy to the test drug, who required more than one attempt  at insertion and those with pre-operative sore throat or already on analgesics or steroids (systemic or inhaled) will be excluded from the study.

The patients will be randomly assigned into two equal groups, C and D, based on computer-generated random sequence of numbers. Concealment will be achieved by closed envelope technique. Standard general anaesthesia protocol will be followed in both groups. Patients will receive oral ranitidine 150 mg, metoclopramide10 mg, and alprazolam 0.25 mg on the night before surgery and ranitidine 150 mg and metoclopramide 10 mg on the morning of

surgery. In the operation theatre, intravenous (IV) cannula will be inserted and monitoring with electrocardiography, noninvasive blood pressure monitor, and pulse‑oximeter will be done. Patients will be preoxygenated with 100% O₂; glycopyrrolate 0.2 mg, midazolam 2 mg, and fentanyl 2 µg/kg will be given intravenously. In addition Group D patients will receive 8mg IV dexamethasone. They will then be induced with IV propofol 1.5–2.5 mg/kg till there is loss of response to verbal Command and patient becomes apnoeic. Classic LMA size 3/4 will be inserted after full deflation. Patient will be maintained on O₂, N2O and isoflurane 0.5%–1.5%. LMA cuffs will be filled with 20/30 ml of room air. If >1attempt will be required for insertion, the patients will be excluded from the study. Drugs will be given by anesthetist posted in the theatre. The cuff pressure will be measured and will be set to 25 cmH2O using Portex cuff inflator (manufacturer: Smiths Medical International Ltd., UK) in both groups. Patients will be maintained on spontaneous ventilation. Rise in heart rate and/or mean arterial pressure more than 20% from the baseline value will be initially treated with increasing the inspired concentration of isoflurane to 1.5%–2%. If there was no response, IV 20 μg boluses of fentanyl will be given. Toward the end of surgery, IV ondansetron 4 mg and IV paracetamol 1 g will be given to all patients. On completion of surgery, LMA will be removed after suctioning and deflating the cuff. Four hours after surgery all patients wil receive oral paracetamol 650 mg 8th hourly. Patients will be given rescue analgesia with IV tramadol 1mg.kg−1 if the patient complained of pain. The total dose of tramadol given in the first 24 h will be noted for both groups. Postoperative sore throat, cough, hoarseness, VAS scores, nausea, vomiting, monitoring will be done in the Intensive Care Unit (ICU) by the anaesthetist who will be blinded and the responses will be noted at 0, 2, 4, 12, and 24 h.

The patients will be asked to grade POST, cough, and hoarseness using a predefined category scale with scores 0–3 and nausea vomiting will be graded as 0-2. Total intra-operative as well as post-operative opioid consumptions will be documented.