Skip to content

Maintaining of remifentanil infusion until extubation

Study of the effects of maintaining remifentanil infusion until tracheal extubation on the recovery profile and hemodynamic variables in the patients with elective craniotomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012110711398N1
Enrollment
62
Registered
2013-05-04
Start date
2012-08-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: Craniotomy of supratentorial lesion. Condition 2: Craniotomy of supratentorial lesion. Condition 3: Craniotomy of supratentorial lesion. Brain, supratentorial ????? ????? ??? Brain, supratentorial

Interventions

Intervention 1: In the case group with last skin suture, infusion of propofol will be ceased but the infusion of remifentanil continued with the half dose of surgery time until response to verbal stim
Prevention
Placebo
In the case group with last skin suture, infusion of propofol will be ceased but the infusion of remifentanil continued with the half dose of surgery time until response to verbal stimulation by patie
In the control group, with the conclusion of surgery both drugs (propofol & remifentanil) will be discontinued and for blinding infusion of normal saline as placebo will starts.

Sponsors

Research Deputy of Medicine Faculty, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients who candidated to supratentorial craniotomy, Age from 18 to 65 years, ASA physical class I-II, preoperative GCS > 13 Eexclusion criteria: age> 65 II, GCS< 13, any allergy to the drugs of study, history of smoking, COPD, chronic cough, asthma, HTN, difficult airway and recent upper respiratory tract infections

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Coughing & bucking intensity. Timepoint: during tracheal extubation. Method of measurement: Minogue Scale.;Mean Arterial Pressure. Timepoint: Each 2 minutes from last skin suture or Mayfield opening until extubation and each 2 minutes after extubation until 10 minute later/each 5 minutes until 15 minute later in recovery room. Method of measurement: Automatic noninvasive sphigmomanumeter.;Heart rate. Timepoint: Each 2 minutes from last skin suture or Mayfield opening until extubation and each 2 minutes after extubation until 10 minute later/each 5 minutes until 15 minute later in recovery room. Method of measurement: Pulse oximeter.

Secondary

MeasureTime frame
Time interval to awakening after discontinuing of anesthesia drug. Timepoint: Verbal stimulation every min after discontinuing of propofol. Method of measurement: Time to opening of eye with stimulation by cornometer.;Nausea & vomiting pervalance and intensity. Timepoint: Each 15 minutes until 1 hour in recovery room. Method of measurement: Four points score: 1 no sign, 2 mild, 3 moderate, 4 severe.;Concsiousness level. Timepoint: Each 15 minutes until 1 hour in recovery room. Method of measurement: GCS (Glasco coma scale).;Reoperation incidance rate. Timepoint: Till 48 houres after operation. Method of measurement: Sergeon's decision.;Arrythemia incidance rate. Timepoint: After the last suture or Mayfield opening till O.R abondonment. Method of measurement: Contineous ECG monitoring.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Hossein Bagheri Aghdam MD.

Tehran University of Medical Sciences

homopersicus@yahoo.com+98 21 8214 1360

Outcome results

None listed

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