Preoperative Dexmedetomidine & EC50 of Propofol

NCT02097407 | Completed Phase 4

• 1 other identifier: PreopDXM_PPF
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine is a useful anaesthetic adjuvant for general anaesthesia. In this prospective randomised study, we determined whether preoperative dexmedetomidine administration could reduce the half maximal effective concentration (EC50) of propofol for successful i-gelTM insertion without muscle relaxants.

Conditions

Urologic Surgery

Outcome Measures

Primary Outcomes (1)

• EC50 of propofol required for successful i-gel insertion

  The EC50 of propofol for successful i-gel insertion was determined by a modification of Dixon's up-and-down method. The response of each patient determined the effect-site propofol concentration for the next patient. If the response was deemed 'successful', the next target concentration of propofol was decreased by 0.5 µg mL-1. If the response was deemed a 'failure', the target concentration was increased by the same dose. The process was repeated until the sixth crossover point (success/failure) was obtained.

  During i-gel insertion anticipated up to 1 min

Secondary Outcomes (2)

• the total dose of propofol infused before i-gel insertion

  During i-gel insertion time anticipated upto 1min

• the presence/severity of airway trauma after i-gel insertion

  At the time point of removing the i-gel from patient's mouth

Study Arms (2)

Group D : Dexmedetomidine + propofol group

EXPERIMENTAL

In Group D, DEX (1 µg kg-1) was intravenously loaded for 10 min before induction of anaesthesia.

Drug: Group D : Dexmedetomidine + propofol group

Group C : Saline + propofol group

PLACEBO COMPARATOR

In Group C, 0.9% of normal saline (1 µg kg-1) was loaded 10 min before induction of anaeshtesia.

Drug: Group C : Saline + propofol group

Interventions

Group C : Saline + propofol group DRUG

All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of normal saline. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group C received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min. After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment

Group C : Saline + propofol group

Group D : Dexmedetomidine + propofol group DRUG

All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of dexmedetomidine. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group D received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min. After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment.

Group D : Dexmedetomidine + propofol group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-II patients who were 20-65 years old and scheduled for general anaesthesia for urologic surgery

You may not qualify if:

• Patients with an allergy to alpha-2 adrenergic agonists or propofol
• Patients who anticipated difficult airway (cervical spinal disease, Mallampati score of III or IV, a mouth opening of \<2.5 cm, and/or body mass index of \>30 kg m-2), unstable teeth
• Patients with bradycardia of \<50 beats/min, heart block greater than first degree, severe cardiorespiratory dysfunction
• Patients with symptoms of upper respiratory infection

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University of Hospital

Seoul, 110-799, South Korea

Location

Related Publications (1)

• Jang YE, Kim YC, Yoon HK, Jeon YT, Hwang JW, Kim E, Park HP. A randomized controlled trial of the effect of preoperative dexmedetomidine on the half maximal effective concentration of propofol for successful i-gel insertion without muscle relaxants. J Anesth. 2015 Jun;29(3):338-345. doi: 10.1007/s00540-014-1949-9. Epub 2014 Nov 14.

  PMID: 25394762 DERIVED

Study Officials

• Hee Pyung Park, MD PhD

  Professor

  STUDY DIRECTOR

• Young Cheol Kim, Md PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 27, 2014
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

KR (1)