EFFECT OF INTRACUFF DEXAETHASONE ON POSTOPERATIVE SORE THROAT IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 40
- Primary Endpoint
- Incidence of postoperative sore throat (POST)
Study Overview
Brief Summary
Postoperative sore throat is the most common complication following general anesthsia with endotracheal intubation with incidence ranging from 21 to 65% Although usually self-limiting, it significantly affects patient's comfort, satisfaction and may adversely affect the quality of recovery in postoperative period.
Laparoscopic cholecystectomy is one of the most performed laparoscopic surgeries and is routinely carried out under general anesthesia with endotracheal intubation. Several factors associated with this procedure like mechanical manipulation of airway during laryngoscopy and intubation, prolonged pressure of endotracheal tube cuff on the tracheal mucosa, pneumoperitoneum and positional changes during surgery may increase the risk of postoperative airway irritation and inflammation leading to sore throat, cough, hoarseness of voice.
various methods have been used for prevention of postoperative sore throat including topic local anesthetics, lubricants and systemic corticosteroid. Among sytemic steroid, Dexameathsone has shown to reduce airway inflammation and postoperative airway complications. However systemic administration may be associated with adverse effects such as hyperglycaemia, immunosupression and delayed wound healing.
Intracuff administration of dexamethasone provides an alternative approach that may help reduce postoperative airway complications while minimising systemic exposure. In this approach drug is instilled into the endotracheal tube cuff, causing it to gradually diffuse across the cuff membrane exerts local anti- inflammatory effect on the tracheal mucosa, thereby reducing inflammation and irritation exerts local anti- inflammatory effect on the tracheal mucosa, thereby reducing inflammation and irritation.
This study aims to evaluate the effect of intracuff dexamethasone on the incidence and severity of postoperative sore throat in patients undergoing laparoscopic cholecystectomy. The primary objective is to compare the incidence of postoperative sore throat between patients receiving intracuff dexamethasone and those receiving intracuff normal saline. Secondary objective includes comparing the severity of postoperative sore throat as well as the incidence and severity of postoperative cough and hoarseness of voice assessed within first 24 hours of surgery.
The study will be conducted as a prospective, double blind randomised controlled trial in the routine operation theatre of BP Koirala Institute of Health Sciences(BPKIHS),Dharan, Nepal. A total of 40 adult patients aged 18-65 years with ASA PS I or II and scheduled for elective laparoscopic cholecystectomy will be included. Participants will be randomly allocated in two groups in a ratio of 1:1. In the intervention group, cuff will be inflated with dexamethasone(0.01mg/g) diluted with normal saline, while in control group the cuff will be inflated with normal saline alone.
Postoperative sore throat, cough and hoarseness of voice will be assess at 2,6, 12 and 24 hours after extubation using standardised grading scale. Data will be analysed using SPSS software and MS Excel.
Continuous variables will be compared using the independent t test while the categorical variables will be analysed using the chi-square test or Fisher's test. A P value of<0.05 will be considered statistically significant.
Ethical approval will be obtained from the IRC of BPKIHS and NHRC. This study may help identify a simple and cost effective strategy to reduce postoperative airway discomfort and improve patient recovery after laparoscopic cholecytectomy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The study solution is prepared by an independent anesthesiologist who is not involved in patient management or outcome assessment. Participants, anesthesia providers, investigators, and postoperative outcome assessors remain blinded to treatment allocation until completion of data analysis.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patient aged 18-65 years.
- •Either sex
- •ASA physical status I or II
- •Mallampatti grade I and II.
- •Patient scheduled for elective laparoscopic cholecystectomy
- •Patient requiring general anesthesia with endotracheal intubation
- •Expected duration of surgery <2 hours.
- •Patients /patient's family member who provide written informed consent.
Exclusion Criteria
- •Refusal for consent
- •Mallampati grade III or IV
- •More than two attempts at endotracheal intubation.
- •Reintubation
- •Use of bougie or stylet for intubation.
- •Evidence of traumatic intubation (blood stained secretions or blood on ETT cuff)
- •Preexisting sore throat, hoarseness of voice or upper respiratory tract infection.
- •Patient receiving systemic or inhaled steroids.
- •Known case of allergy to dexamethasone.
Arms & Interventions
Intracuff Dexamethasone
Participants receive dexamethasone 0.1 mg/kg diluted with normal saline to inflate the cuff of the endotracheal tube immediately after tracheal intubation. General anesthesia and perioperative management are standardized according to the study protocol.
Intervention: Dexamethasone (0.1 mg/kg) (Drug)
Intracuff Dexamethasone
Participants receive dexamethasone 0.1 mg/kg diluted with normal saline to inflate the cuff of the endotracheal tube immediately after tracheal intubation. General anesthesia and perioperative management are standardized according to the study protocol.
Intervention: Normal Saline (0.9% NaCl) (Drug)
Intracuff normal saline
Participants receive normal saline to inflate the cuff of the endotracheal tube immediately after tracheal intubation. General anesthesia and perioperative management are otherwise identical to those of the experimental group.
Intervention: Dexamethasone (0.1 mg/kg) (Drug)
Intracuff normal saline
Participants receive normal saline to inflate the cuff of the endotracheal tube immediately after tracheal intubation. General anesthesia and perioperative management are otherwise identical to those of the experimental group.
Intervention: Normal Saline (0.9% NaCl) (Drug)
Outcomes
Primary Outcomes
Incidence of postoperative sore throat (POST)
Time Frame: Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively)
Secondary Outcomes
- Severity of postoperative sore throat(Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively))
- Incidence of postoperative cough(Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively))
- Incidence of postoperative hoarseness of voice(Within 24 hours after extubation (assessed at 2, 6, 12, and 24 hours postoperatively))
Investigators
MONIKA KC
Junior resident
B.P. Koirala Institute of Health Sciences