A clinical study to compare the effectiveness of reducing post operative sore throat in tonsillectomy following dexmedetomidine intraoral spray versus ketamine intraoral spray

Phase 4

Not yet recruiting

• Conditions: Chronic tonsillitis and adenoiditis,

• Registration Number: CTRI/2024/03/063919
• Lead Sponsor: Dr Ranadhee Paul

Brief Summary

Tracheal or nasal intubation for general anesthesia causes airway mucosa trauma resulting in postoperative sore throat (POST), hoarseness, and cough . POST is a minor and common problem in patients undergoing endotracheal intubation , which commonly occurs 12 to 24 hours after the operation. Despite the mildness of symptoms, POST is one of the major cause of post operative dissatisfaction after surgery . In most cases, POST heals after surgery without specific treatment. Moderate to severe POSTS with dysphagia and pain can be treated with pharmacological agents.

Ketamine, a dissociative anesthetic agent, is the most potent of NMDA antagonists. Ketamine interacts noncompetitively with the NMDA receptors, suppresses the NMDA receptor mediated central sensitization, and potentially decreases postoperative pain

Dexmedetomidine is an alpha2 adrenergic agonists which have sedative, hypnotic  ,anxiolytic, analgesic, and sympatholytic effects. The analgesic effect of dexmedetomidine is mediated through stimulation of alpha 2c and alpha 2a receptors in the dorsal horn directly suppressing pain transmission by reducing the release of pronociceptive transmitters, substance P and glutamate and hyperpolarization of interneurons.

Therefore, this study attempted primarily to shed light upon the efficacy of dexmedetomidine intraoral spray versus ketamine intraoral spray on reducing postoperative sore throat  after tonsillectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-04
• Last Update Posted: 2024-08-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Only ASA I and II without any anticipated difficult airway (MPS -I & II) will be included .
• 2.Patients between age 12-30 years 3.Patients of both sexes 4.Patients scheduled for elective tonsillectomy under general anaesthesia.

Exclusion Criteria

• 1.Refusal to valid informed consent.
• 2.History of allergy to the study drugs.
• Patients with Cardiovascular, respiratory, renal , hepatic or neuromuscular diseases.
• Patients with a history of preoperative sore throat, asthma, respiratory tract infection,consumption of analgesic in preoperative period, operating time more than 90 minutes, and requirement of more than one attempt for passage of endotracheal tube.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether Dexmedetomidine or Ketamine intraoral spray is more effective in attenuating the post-operative sore throat in tonsillectomy.	Comparing the time required for attenuation of sore throat in the two groups of participants at 0 hour, 2 hours, 6 hours 12 hours 18 hours and 24 hours post operatively.

Secondary Outcome Measures

Name	Time	Method
To evaluate any adverse effects of the drugs used i.e. Dexmedetomidine & Ketamine intraoral spray.	To evaluate adverse effects of the drugs at 0 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours post operatively

Trial Locations

Locations (1)

Silchar Medical College And Hospital; 🇮🇳 Cachar, ASSAM, India

Silchar Medical College And Hospital

🇮🇳Cachar, ASSAM, India

Dr Ranadhee Paul

Principal investigator

7002334288

binoy.bihari@gmail.com