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The effect of dexmedetomidine after craniotomy in sedation and its complication

The effect of dexmedetomidine infusion after craniotomy on sedation and its complications in the intensive care unit and its comparison with the control group

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170716035104N2
Enrollment
60
Registered
2019-04-21
Start date
2018-12-22
Completion date
Unknown
Last updated
2019-05-21

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

Conditions

Craniotomy. Cranial nerve disorder, unspecified

Interventions

Intervention 1: After the completion of the surgery, the intervention group will receive a dose of 1 microgram per kilogram of body weight diluted in a volume of 20 ml for 10 minutes and a repeated do

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age between 20 and 80 years Candidate for craniotomy Intubation of patients after surgery Being under mechanical ventilation for up to 24 hours Patient consent to participate in the study

Exclusion criteria

Exclusion criteria: Surgical time shorter than 30 minutes Cardiac arrest Drug allergy Third-degree atrioventricular block A heart rate below 45 per minute Systolic pressure below 80 mmHg Not consenting to take part in the study Unavailability of the patient or the inability to follow the patient

Design outcomes

Primary

MeasureTime frame
Sedation score based on Richmond Agitation Sedation scale. Timepoint: In the 30th minute and 4th, 8th, 12th, 16th, 20th and 24th hour after the patient's admission to the recovery. Method of measurement: Richmond Agitation Sedation scale.;Complications due to Dexmedetomidine intake. Timepoint: In the 30th minute and 4th, 8th, 12th, 16th, 20th and 24th hour after the patient's admission to the recovery and until the discharge of the patient. Method of measurement: Questionnaire.;The satisfaction of the patient's nurse according to the Visual Analogue Scale. Timepoint: After the completion of the surgery and before entering the recovery. Method of measurement: The Visual Analogue Scale (VAS).

Secondary

MeasureTime frame
Systolic blood pressure (mm Hg). Timepoint: In the 30th minute and 4th, 8th, 12th, 16th, 20th and 24th hour after the patient's admission to the recovery. Method of measurement: Clinical mercury manometer.;Diastolic blood pressure (mm Hg). Timepoint: In the 30th minute and 4th, 8th, 12th, 16th, 20th and 24th hour after the patient's admission to the recovery. Method of measurement: Clinical mercury manometer.;Heart rate (beats per minute). Timepoint: In the 30th minute and 4th, 8th, 12th, 16th, 20th and 24th hour after the patient's admission to the recovery. Method of measurement: Beat count by palpating distal radius pulse.;Peripheral capillary oxygen saturation (percentage). Timepoint: In the 30th minute and 4th, 8th, 12th, 16th, 20th and 24th hour after the patient's admission to the recovery. Method of measurement: Pulse oximetry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Taghi Hashemi

Esfahan University of Medical Sciences

st_hashemi@yahoo.com+98 31 3270 9537

Outcome results

None listed

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