Study to assess the usefulness of a new drug, Dexmedetomidine, for sedation of patients during insertion of a tube in the wind pipe using endoscopy before anaesthesia

To study the effectiveness of â??Dexmedetomidineâ?? for sedation in elective awake fibre-optic intubation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/08/002858

Enrollment

Registered

2012-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients requiring awake fibreoptic intubation prior to induction of general anaesthesia

Interventions

Intervention1: Dexmedetomidine: single intravenous loading dose of Dexmedetomidine 1.0mcg/kg over 10 mins Control Intervention1: Placebo: intravenous 0.9% sodium chloride for injection in volume simil

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients undergoing major head and neck surgeries scheduled for an elective nasal awake fibreoptic intubation due to an anticipated difficult airway 2)ASA Physical Status I-II.

Exclusion criteria

Exclusion criteria: 1)Pregnant or lactating females 2)Use of an Î±-2-adrenoreceptor agonist or antagonist within 14 days 3)Use of an opiod administered orally or intravenously within 1 hr or intramuscularly within 4 hrs 4)Presence of increased intracranial pressure or CSF leak 5)Acute alcohol intoxication 6)Uncontrolled seizure disorder 7)History of acute unstable angina 8)Laboratory in acute MI within past 6wks 9)Heart rate 50 beats per minute 10)Systolic blood pressure 90mmhg 11)Complete heart block unless patient had a pacemaker 12)Liver transaminase level 2 times the upper normal limit.

Design outcomes

Primary

Measure	Time frame
1)Ease of intubation:(acceptable score 3 to 6; not acceptable 6): median score and no. of patients 2)Percentage of patients requiring Midazolam for rescue sedation to achieve or maintain Ramsay Sedation Scale â?¥2 throughout the study. 3)Patient tolerance of procedure (no. of patients with a tolerance score of 1 or 2) 4)Patient cooperation (no. of patients with a score of 1) Timepoint: Till completion of fibreoptic intubation and induction of general anaesthesia	—

Measure

Time frame

1)Ease of intubation:(acceptable score 3 to 6; not acceptable 6): median score and no. of patients 2)Percentage of patients requiring Midazolam for rescue sedation to achieve or maintain Ramsay Sedation Scale â?¥2 throughout the study. 3)Patient tolerance of procedure (no. of patients with a tolerance score of 1 or 2) 4)Patient cooperation (no. of patients with a score of 1) Timepoint: Till completion of fibreoptic intubation and induction of general anaesthesia

—

Secondary

Measure	Time frame
1)Mean dose of Midazolam required and number of patients in each group requiring resuce midazolam 2)Haemodynamic instability 3)Anaesthesiologistâ??s assessment of ease of patient care (either easy or not easy) 4)Recall of anxiety, pain and the procedure itself during the AFOI.Timepoint: upto 24 hours after the procedure	—

Countries

India

Contacts

Public ContactJV Divatia

Tata Memorial Hopsital

ckd7582@gmail.com

Outcome results

None listed

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