Dexmedetomidine for Double lumen tube insertion

The Effect of Dexmedetomidine on Hemodynamic Response during Double-Lumen tube Insertion: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037238

Enrollment

Registered

2021-10-11

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: J852- Abscess of lung without pneumonia Health Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

Intervention1: Dexmedetomidine: 0.5 mcg/Kg iv Bolus 10 minutes prior to induction of anaesthesia Control Intervention1: Normal Saline Placebo: IV bolus given 10 minutes prior to induction of anaesthes

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients undergoing elective lung surgery, including pulmonary lobectomy, pneumonectomy, metastasectomy, decortication, etc. who require Left-sided DLT placement 2.Patients belonging to ASA physical status I to III

Exclusion criteria

Exclusion criteria: 1.Patients with difficult airway. 2.Surgeries requiring Right sided Double-Lumen tube insertion. 3.Uncontrolled hypertensives. 4.Heart disease with ejection fraction less than 40%, 5.Body mass index (BMI) more than 35 kg/m2, 6.History suggestive of sensitivity to drugs used during the study 7.Patients with bradycardia (heart rate 8.Hepatic or renal impairment 9.Pregnancy

Design outcomes

Primary

Measure	Time frame
The primary endpoint was to compare the hemodynamic responses(defined as a change in heart rate or systolic blood pressure or both by more than 20% of their baseline values prior to induction of anaesthesia) between dexmedetomidine and placebo given in addition to the drugs used in our current standard of care during laryngoscopy and DLT insertion.Timepoint: At baseline(Prior to any drug administration), at laryngoscopy and double lumen tube insertion(Which effectively happen at the same time) and every minute after intubation for the first five minutes, then every five minutes until placement of tube is confirmed by fiber-optic bronchoscopy	—

Measure

Time frame

The primary endpoint was to compare the hemodynamic responses(defined as a change in heart rate or systolic blood pressure or both by more than 20% of their baseline values prior to induction of anaesthesia) between dexmedetomidine and placebo given in addition to the drugs used in our current standard of care during laryngoscopy and DLT insertion.Timepoint: At baseline(Prior to any drug administration), at laryngoscopy and double lumen tube insertion(Which effectively happen at the same time) and every minute after intubation for the first five minutes, then every five minutes until placement of tube is confirmed by fiber-optic bronchoscopy

—

Secondary

Measure	Time frame
To assess the incidence of hypotension and bradycardiaTimepoint: After study drug administration prior to induction of anaesthesia, 3 minutes after induction just before Double Lumen Tube insertion, at laryngoscopy and Double lumen tube insertion, and every minute after intubation for the first five minutes, then every five minutes until placement of tube is confirmed by fiber-optic bronchoscopy;To assess the intraoperative requirement of rescue medication (PNP, Ephedrine) to treat the hypotension and bradycardiaTimepoint: Immediately after study drug administration prior to induction of anaesthesia, 3 minutes after induction just before Double Lumen Tube insertion, at laryngoscopy and Double lumen tube insertion, and every minute after intubation for the first five minutes, then every five minutes until placement of tube is confirmed by fiber-optic bronchoscopy;To assess the requirement of additional anaesthetic drugs (fentanyl, propofol) in order to maintain the hemodynamics within 20% of baseline valuesTimepoint: During laryngoscopy and DLT insertion, and every minute after intubation for the first five minutes, then every five minutes until placement of tube is confirmed by fiber-optic bronchoscopy	—

Measure

Time frame

To assess the incidence of hypotension and bradycardiaTimepoint: After study drug administration prior to induction of anaesthesia, 3 minutes after induction just before Double Lumen Tube insertion, at laryngoscopy and Double lumen tube insertion, and every minute after intubation for the first five minutes, then every five minutes until placement of tube is confirmed by fiber-optic bronchoscopy;To assess the intraoperative requirement of rescue medication (PNP, Ephedrine) to treat the hypotension and bradycardiaTimepoint: Immediately after study drug administration prior to induction of anaesthesia, 3 minutes after induction just before Double Lumen Tube insertion, at laryngoscopy and Double lumen tube insertion, and every minute after intubation for the first five minutes, then every five minutes until placement of tube is confirmed by fiber-optic bronchoscopy;To assess the requirement of additional anaesthetic drugs (fentanyl, propofol) in order to maintain the hemodynamics within 20% of baseline valuesTimepoint: During laryngoscopy and DLT insertion, and every minute after intubation for the first five minutes, then every five minutes until placement of tube is confirmed by fiber-optic bronchoscopy

—

Countries

India

Contacts

Public ContactDr Gladdy George

Christian Medical College, Vellore

harigovind7@gmail.com8489865241

Outcome results

None listed

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