Effect of injection of local anaesthetic into trachea on the incidence of postoperative sore-throat in patients undergoing robotic gynaecological surgeries

Phase 3

Recruiting

• Conditions: Inflammatory diseases of female pelvic organs,

• Registration Number: CTRI/2020/04/024956
• Lead Sponsor: Amrita Institute of Medical Sciences

Brief Summary

Effectof trans-tracheal injection of local anaesthetic on the incidence ofpost-operative sore-throat in patients undergoing robotic assistedgynaecological surgeries under general anaesthesia- A Randomized control trial

**Backgroundand Aims:**

Postoperative sore-throat (POST) isa major concern for patients undergoing any surgery under general anaesthesia.Patients undergoing roboticassistedgynaecological surgeries have much lesser surgical pain and shorter hospitalstay when compared to patients undergoing open surgeries. But it is noticedthat majority of these patients complain of sore-throat and hoarseness. Thismay be attributed to the steep Trendlenburg positioning used during theprocedure which could lead to airway oedema. Methods to reduce the POST andhoarseness will allow faster postoperative recovery and better patientsatisfaction. This study is performed to assess the effectiveness of single dose 5mlof trans-tracheal lignocaine 4% on the incidence of POST, hoarseness and coughin patients undergoing robotic assisted gynaecological surgeries under generalanaesthesia.

**Methods**

This prospective, randomised, single 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 robotic assisted gynaecologicalsurgeries lasting 2-3h under general anaesthesia with endotracheal tube will beincluded in this study. Patients with anticipated difficult airway, history ofallergy to the test drug, who required more than one attempt  at intubation and those with pre-operativesore throat or already on analgesics or steroids (systemic or inhaled) will beexcluded from the study.

The patients will be randomlyassigned into two equal groups, L and S, based on computer-generated randomsequence of numbers. Concealment will be achieved by closed envelope technique.Standard general anaesthesia protocol will be followed in both groups. Patientswill receiveoral ranitidine 150 mg, metoclopramide10 mg, and alprazolam 0.25 mg on thenight before surgery and ranitidine 150 mg and metoclopramide 10 mg on themorning of

surgery. In theoperation theatre, intravenous (IV) cannula will be inserted and monitoringwith electrocardiography, noninvasive blood pressure monitor, and pulse‑oximeter will be done.Patients in group L will receive trans-tracheal injection of 5ml of 4%lignocaine and group P will receive trans-tracheal injection of 5ml of 0.9%saline.

Patients will be preoxygenated with 100% O2;glycopyrrolate 0.2 mg, midazolam 2 mg, and fentanyl 2 µg/kg will be givenintravenously. They will then be induced with IV propofol 1.5–2.5 mg/kg tillthere is loss of response to verbal command and muscle relaxant atracurium willbe given. Patient will be maintained on O2, air and sevoflurane. If>1attempt will be required for intubation, the patients will be excludedfrom the study. The cuff pressure will be measured and will be set to 25 cmH2Ousing Portex cuff inflator (manufacturer: Smiths Medical International Ltd.,UK) in both groups.

Toward the end of surgery, IV ondansetron 4 mgand IV paracetamol 1 g will be given to all patients. Four hours after surgeryall patients will receive oral paracetamol 650 mg 8th hourly. Patients will begiven rescue analgesia with IV tramadol 1mg/kg if the patient complained ofpain. The total dose of tramadol given in the first 24 h will be noted for bothgroups. Postoperativesore throat, cough and hoarseness will be monitored 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 predefinedcategory scale with scores 0–3. Total intra-operative as well aspost-operative opioid consumptions will be documented.

**Categoryscale score for assessment of sorethroat/hoarseness/cough**

**GradeSeverity**

0No sore throat/hoarseness/cough

1Minimal ‑ Patient answered inthe affirmative when asked

2Moderate ‑.Patientcomplained on her own

3Severe ‑.Patient in obvious distress

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-05
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

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

Inclusion Criteria

Patients of the American Society of Anaesthesiologists (ASA) physical status 1-2 undergoing robotic-assisted gynaecological surgeries lasting 2-3h under general anaesthesia with the endotracheal tube 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 intubation 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
Postoperative sore throat	upto 24h postoperatively

Secondary Outcome Measures

Name	Time	Method
Post operative cough and hoarsness	Postoperive period upto 24h

Trial Locations

Locations (1)

Amrita Institute of medical Sciences; 🇮🇳 Ernakulam, KERALA, India

Amrita Institute of medical Sciences

🇮🇳Ernakulam, KERALA, India

Nitu PV

Principal investigator

09495962020

nituveesundeep@gmail.com