observing the intravenous drugs ketamine, dexmeditomidine and combination of ketamine of dexmeditomidine in the mitigation of agitation following general anaesthesia in patients undergoing nasal surgeries

Phase 4

Not yet recruiting

• Conditions: Other diseases of upper respiratory tract,

• Registration Number: CTRI/2023/07/055886
• Lead Sponsor: John Mammen

Brief Summary

Emergence agitation is a common side effect seen following nasal surgeries. Emergence agitation involves restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anaesthesia and can cause injury to patients and unwanted accidents in the operation theatre and post anaesthesia care unit. Various drugs have been used to decrease the incidence of emergence agitation following nasal surgeries.We are comparing the effects of three drugs ketamine, dexmedetomidine and a combination of ketamine and dexmedetomidine ie; ketodex which are routinely used to ameliorate or prevent emergence agitation, by comparison of recovery characteristics including extubation and Recovery time( Time in minutes from when inhalation agent is discontinued,to response to first verbal command);Level of agitation assessed by Riker Sedation Agitation Scale,level of painwill be assessed by Numeric pain rating scale;Hemodynamic parameters will be compared at regular intervals  at post operative anaesthesia care unit;Post operative nausea vomiting will be assessed by 4 Point Post operative nausea and vomiting scale ;and Discharge time at arrival to post-anaesthesia care unite (PACU) to discharge to the ward according to modified Aldrete score, patients having Aldrete score of 9 or higher will be discharged to the ward.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-30
• Study Start: 2023-10-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients of either sex scheduled for elective nasal surgeries under general anaesthesia -American society of Anesthesiologists physical status I,II.

Exclusion Criteria

Patients with altered mental status Patients on psychoactive/analgesics/ Beta agonist drugs Pregnant women Patient with known allergy or hypersensitivity to the drugs used in the study Patients with anticipated difficult airway.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the level of emergence agitation in patients receiving ketamine, dexmedetomidine	Level of agitation assessed by Riker Sedation Agitation scale, At recovery & at admission to PACU. hemodynamic parameters, postoperative nausea vomiting and pain scores every 15 minutes till 30 minutes, followed by every 30 minutes for 2 hours at post operative anaesthesia care unit
and ketodex atrecovery from general anaesthesia & admission to post anaesthesia care unit, Hemodynamic parameters, post operative nausea vomiting, pain score	Level of agitation assessed by Riker Sedation Agitation scale, At recovery & at admission to PACU. hemodynamic parameters, postoperative nausea vomiting and pain scores every 15 minutes till 30 minutes, followed by every 30 minutes for 2 hours at post operative anaesthesia care unit

Secondary Outcome Measures

Name	Time	Method
Hemodynamic parameters	every 15 minutes till 30 minutes, followed by every 30 minutes for 2 hours at post operative anaesthesia care unit
Level of pain	Will be assessed by Numeric pain rating scale at admission to postoperative anaesthesia care unit & at discharge from postoperative anaesthesia care unit.
Discharge time in minutes	The time from arrival to post-anaesthesia care unite (PACU) to discharge to the ward according to modified Aldrete score
Post operative nausea vomiting:	assessed by 4 Point Post operative nausea & vomiting scale at admission to post operative care unit and at discharge from post operative care unit
Recovery time	Time in minutes from when sevoflurane is discontinued,to response to first verbal command
Extubation time	Time from discontinuing sevoflurane to extubation.

Trial Locations

Locations (1)

Kasturba medical college; 🇮🇳 Udupi, KARNATAKA, India

Kasturba medical college

🇮🇳Udupi, KARNATAKA, India

Dr John Mammen

Principal investigator

9780062351

karun.2393@gmail.com