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Clinical Trials/CTRI/2024/10/075652
CTRI/2024/10/075652
Not yet recruiting
Not Applicable

Effect of nasal clamping and mouth breathing training in reducing emergence delirium post endoscopic sinus surgery - randomised controlled study

Bangalore Medical College and Research Institute1 site in 1 country100 target enrollmentStarted: October 29, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Bangalore Medical College and Research Institute
Enrollment
100
Locations
1
Primary Endpoint
To assess emergence delirium post nasal surgery

Overview

Brief Summary

Emergence delirium is a short term state of dissociation of consciousness during the recovery from general anaesthesia along with motor agitation,incoherence ,inconsolability and unresponsiveness.(1-3) It is the most common neuropsychiatric complications after surgery . Emergence delirium is self-limiting but sometimes the agitated behaviour may result in post anaesthesia care unit accidents.(4) Emergence delirium may be associated with increased risks of long term adverse outcomes like cognitive dysfunction and negative behaviour that cause lower quality of life, readmission to hospitals ,and even deaths.(5,6) Emergence delirium may arise by an imbalance between the patient’s arousal state and the recovery of consciousness. Interventional strategies like medical interventions - Gabapentin, Dexmeditomidine , Melatonin and Remelteon and non pharmacological interventions such as time and place orientation are employed to reduce the incidence of emergence delirium.(7,8)

During the emergence from anaesthesia, obstruction by nasal packing cause breathing difficulties and a feeling of suffocation due to forceful mouth breathing which increases the risk of emergence delirium. Risk factors for emergence delirium are age,smoking , pre-operative anxiety, types of operation, postoperative pain,etc .(9,10)

The study aims at evaluating the efficacy of preoperative patient training and training with nasal clamping and mouth breathing training on prevention of emergence delirium and to identify associated risk factors for emergence delirium.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients willing to give written informed consent belonging to American Society of Anaesthesiologist I and II undergoing endoscopic sinus surgery, septoplasty and turbinoplasty requiring post surgery nasal packing.

Exclusion Criteria

  • Patients not willing to give informed consent Patients with known allergy to any study drug.

Outcomes

Primary Outcomes

To assess emergence delirium post nasal surgery

Time Frame: To assess emergence delirium with RAS at 1min 5min 10 min 15 min 20 min 25 min 30 min 1hr

Secondary Outcomes

  • To assess opiod requirements over 24 hrs post surgery(To assess NRS and rescue analgesia at immediately,30 min 1hr 2 hr 8hrs 12 hrs 24 hrs)
  • To assess haemodynamic parameters heart rate mean arterial pressure post operatively(To assess haemodynamic parameters heart rate mean arterial pressure immediately 30 min 1hr 2 hr 8hrs 12 hrs 24 hrs)

Investigators

Sponsor
Bangalore Medical College and Research Institute
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Sargam Gupta

Bangalore Medical College and Research Institute Bangalore

Study Sites (1)

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