Effect of single dose of steroid on postoperative sore throat,nausea vomiting and pain in patients undergoing breast surgeries

Phase 3

Recruiting

• Conditions: Malignant neoplasms of breast,

• Registration Number: CTRI/2020/01/022829
• Lead Sponsor: Amrita Institute of Medical Sciences

Brief Summary

Effectof single dose of IV dexamethasone on the incidence of post-operativesore-throat  nausea, vomiting and pain inpatients undergoing breast surgeries- A Randomized control trial

**Backgroundand Aims:**

Breast surgeries are commonly performed undergeneral anesthesia with laryngeal mask airway. Post operatively sore-throat(POST), postoperative nausea, vomiting (PONV) and pain are the main complaintsfollowing breast surgeries. POST can be associated withhoarseness of voice and cough. Even though these symptoms resolvespontaneously, prophylactic management of POST, nausea and vomiting arerecommended to improve the quality of post-anaesthesia care.  Various drugs like ketamine, lidocaine,  magnesium sulphate etc are administered to reducethe incidence of sore-throat. Ondansetron is usually administered to preventPONV. Dexamethasone is a steroid antiemetic used even in cancer patients. Dexamethasoneis also known to reduce POST and reduce postoperative opioid requirement. Hencethis study is performed to assess the effectiveness of single dose of IV dexamethasonegiven pre operatively to reduce the incidence of   POST ,PONV and postoperative opioid consumption.Primary objective is to assess thereduction in incidence and severity of postoperative sore throat in patientsundergoing breast surgery under general anaesthesia with laryngeal mask airway in patients. Secondary objectivesinclude reduction in incidence of postoperative hoarseness of voice,cough,PONV,painscore and postop analgesic requirement.

**Methods**

This prospective, randomised, double blinded studywill 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 theAmerican Society of Anaesthesiologists (ASA) physical status 1–2, undergoing breastsurgeries lasting 2-3h under general anaesthesia with laryngeal mask airwaywill 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 sorethroat or already on analgesics or steroids (systemic or inhaled) will beexcluded from the study.

Thepatients will be randomly assigned into two equal groups, C and D, based oncomputer-generated random sequence of numbers. Concealment will be achieved byclosed envelope technique. Standard general anaesthesia protocol will befollowed in both groups. Patients will receive oral ranitidine150 mg, metoclopramide10 mg, and alprazolam 0.25 mg on the night before surgeryand ranitidine 150 mg and metoclopramide 10 mg on the morning of

surgery.In the operation theatre, intravenous (IV) cannula will be inserted andmonitoring with electrocardiography, noninvasive blood pressure monitor, andpulse‑oximeterwill 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 thenbe induced with IV propofol 1.5–2.5 mg/kg till there is loss of response toverbal Command and patient becomes apnoeic. Classic LMA size 3/4 will beinserted after full deflation. Patient will be maintained on O2, N2Oand 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 fromthe study. Drugs will be given by anesthetist posted in the theatre. The cuffpressure will be measured and will be set to 25 cmH2O using Portex cuffinflator (manufacturer: Smiths Medical International Ltd., UK) in both groups. Patientswill be maintained on spontaneous ventilation. Rise in heart rate and/or meanarterial pressure more than 20% from the baseline value will be initiallytreated with increasing the inspired concentration of isoflurane to 1.5%–2%. Ifthere 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 givento all patients. On completion of surgery, LMA will be removed after suctioningand deflating the cuff. Four hours after surgery all patients wil receive oralparacetamol 650 mg 8th hourly. Patients will be given rescue analgesia with IVtramadol 1mg.kg−1 if the patient complained of pain. The total dose of tramadolgiven in the first 24 h will be noted for both groups. Postoperative sore throat, cough, hoarseness, VASscores, nausea, vomiting, monitoring will be done in the Intensive Care Unit(ICU) by the anaesthetist who will be blinded and the responses will be notedat 0, 2, 4, 12, and 24 h.

Thepatients will be asked to grade POST, cough, and hoarseness using a predefined categoryscale with scores 0–3 and nausea vomiting will be graded as 0-2. Totalintra-operative as well as post-operative opioid consumptions will bedocumented.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

Patients with an 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	0,2,4,12,24h in the postoperative period

Secondary Outcome Measures

Name	Time	Method
Secondary objectives include reduction in incidence of postoperative hoarseness of voice,cough,PONV,pain score and postop analgesic requirement.	0,2,4,12,24 h in the postoperative period

Trial Locations

Locations (1)

Amrita institute of medical sciences; 🇮🇳 Ernakulam, KERALA, India

Amrita institute of medical sciences

🇮🇳Ernakulam, KERALA, India

Dr Nitu

Principal investigator

09495962020

nituveesundeep@gmail.com