Evaluation of different doses of intranasal dexmeditomedine in elderly patients with hypertension undergoing cataract operation.

Comparative evaluation of two different doses of intranasal dexmeditomedine for procedural sedation in hypertensive elderly patients undergoing cataract surgery under peribulbar block - A randomised controlled double blinded trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/041910

Enrollment

Registered

2022-04-19

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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: 0.5mcg/kg of intranasal dexmeditomedine: Route of administration: Intranasal administration Dose of the drug administered: 0.5 mcg/kg. frequency of administration: Once , as a premed

Eligibility

Inclusion criteria

Inclusion criteria: elderly patients having grade 2 hypertension undergoing cataract surgery under peribulbar block, age between 60 to 75 years , BMI between 17.5 and 30 kg/m2, total body weight more than 50 kg , ASA physical status less than 3.

Exclusion criteria

Exclusion criteria: includes patient refusal, low baseline HR less 40bpm, age >75 years, heart block of any degree, known valvular heart disease, known history of renal or hepatic impairment, severe left ventricular dysfunction, obesity BMI more than 30

Design outcomes

Primary

Measure	Time frame
patients experiencing more than 30% decrease in systolic, diastolic or mean arterial blood pressure and the number of patients experiencing bradycardia(HR less than 40bpm) for more than one minute. We will also measure the maximum change of these variables from the baseline in each patient ( the percentage change)Timepoint: every 2.5 minutes for the first 15 minutes and every 5 minutes there after for 2 hours after drug administration	—

Measure

Time frame

patients experiencing more than 30% decrease in systolic, diastolic or mean arterial blood pressure and the number of patients experiencing bradycardia(HR less than 40bpm) for more than one minute. We will also measure the maximum change of these variables from the baseline in each patient ( the percentage change)Timepoint: every 2.5 minutes for the first 15 minutes and every 5 minutes there after for 2 hours after drug administration

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Secondary

Measure	Time frame
The secondary outcome will be the maximum sedation levels being achieved in these patients, [excessive sedation (MOAAS less than or equal to 3 ), hypoventilation with RR less than 8 per min, drop in SpO2 to less than 92% for more than a minute and the need for airway support; nausea and vomiting within 6 hours of administration of Dexmeditomedine, time taken to achieve the maximum sedation levels. The surgeon satisfaction score with the patient cooperation during surgery will be given by the operating surgeon.Timepoint: Levels of sedation, respiratory rate, oxygen saturation levels will be noted every 2.5 min after drug administration for the first 15 minutes and every 5 minutes there after for 2 hours. Surgeon satisfaction score will be noted at the end of the surgery.	—

Measure

Time frame

The secondary outcome will be the maximum sedation levels being achieved in these patients, [excessive sedation (MOAAS less than or equal to 3 ), hypoventilation with RR less than 8 per min, drop in SpO2 to less than 92% for more than a minute and the need for airway support; nausea and vomiting within 6 hours of administration of Dexmeditomedine, time taken to achieve the maximum sedation levels. The surgeon satisfaction score with the patient cooperation during surgery will be given by the operating surgeon.Timepoint: Levels of sedation, respiratory rate, oxygen saturation levels will be noted every 2.5 min after drug administration for the first 15 minutes and every 5 minutes there after for 2 hours. Surgeon satisfaction score will be noted at the end of the surgery.

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Countries

India

Contacts

Public ContactDr Vineetha Subba Karadka

nethradhama superspeciality eye hospital

drvineethask@gmail.com9980135958

Outcome results

None listed

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