A clinical trial to study the effect of the drug Dexmedetomidine in controlling agitation which occurs after general anesthesia in oral and nasal surgeries

To determine the efficacy of Dexmedetomidine, used intraoperatively as an adjunct, in attenuation of Emergence Agitation in Oral and Nasal Surgeries while using Desflurane for maintenance of General Anaesthesia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/12/038949

Enrollment

100

Registered

2021-12-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine: Dexmedetomidine @ 0.3 Âµg/kg /hour 5 minutes before induction and stopped at the time of reversal Control Intervention1: Normal Saline: NS @ 20ml/hour 5 minutes before

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA I and II 2.Patients undergoing elective nasal and oral surgical procedure under GA 3.Procedure duration of 60 - 240 minutes

Exclusion criteria

Exclusion criteria: 1. Refusal by patient 2. ASA III and more 3. Patient on MAO inhibitors &Beta-adrenergic blocking drugs 4. Suspected allergy to a2 adrenergic agonist or NSAIDS 5. Patients with severe bradyarrhythmia secondary to AV block 6. Ischemic heart disease and valvular heart disease 7. Cognitive impairment 8. Psychiatric illness

Design outcomes

Primary

Measure	Time frame
To determine the efficacy of dexmedetomidine in the prevention of EA after nasal or oral surgeries under GA in adultsTimepoint: Emergence agitation is observed using Richmond Agitation Sedation Scale Score during immediate post op period	—

Secondary

Measure	Time frame
1. To determine the difference in the RASS with and without the use of dexmedetomidine in oral and nasal surgeries under GA. 2. To compare the Hemodynamic stability between the groups. 3. To compare the time to respond to verbal commands between the groups. 4. To determine the difference in time to extubation after switching off inhalational agent between the groups Timepoint: Standard monitoring HR, NIBP, EtCO2, ECG intraoperatively and hemodynamic were recorded at pre-induction level, induction, intubation, reversal, at the time of response to verbal command, at the time of extubation and 5 minutes post-extubation. Time to respond to verbal commands and time to extubation after discontinuation of inhalational agents were recorded.	—

Measure

Time frame

1. To determine the difference in the RASS with and without the use of dexmedetomidine in oral and nasal surgeries under GA. 2. To compare the Hemodynamic stability between the groups. 3. To compare the time to respond to verbal commands between the groups. 4. To determine the difference in time to extubation after switching off inhalational agent between the groups Timepoint: Standard monitoring HR, NIBP, EtCO2, ECG intraoperatively and hemodynamic were recorded at pre-induction level, induction, intubation, reversal, at the time of response to verbal command, at the time of extubation and 5 minutes post-extubation. Time to respond to verbal commands and time to extubation after discontinuation of inhalational agents were recorded.

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Countries

India

Contacts

Public ContactKarthik Devarajan

Operation theatre, Department of Anesthesia

drkartideva@gmail.com9894792939

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026