Remifentanil and Midazolam on Propofol for Loss of Consciousness in Elderly Patients

NCT02818387 | Unknown DMC

• 1 other identifier: 3-2015-0222
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Propofol is a well-known induction agent which can provide sound and quick hypnosis with anti-emetic effects. However, dose dependent hypotension or bradycardia have reported while using this agent. Propofol in combination with remifentanil or midazolam can result in synergistic or additive effect in elderly patients. There are not many studies which provide minimum dose of propofol to induce hypnosis in combination with these agents and advantage of the combination. The elderly patients (over 65 years old) who are scheduled to undergo general anesthesia are enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR). Sample size have been decided due to the previous studies which have mentioned 40 participants as a adequate sample size for this biased coin design - up and down study. After receiving informed consent, patients will be participated in this study. No premedication will be given to the patients before induction. The patients in group P will receive general anesthesia only with propofol and group PR and PMR will receive 0.125 mcg/kg/min remifentanil infusion for 5 min prior to propofol administration. The patients in group PMR will receive 0.015 mg/kg bolus dose of midazolam 1 min after the start of the remifentanil infusion. Initial propofol dose will be 0.5 mg/kg in each group and the dose will be changed by the result of prior study participant. 'Success' of this study will be defined as loss of both verbal response and eyelash reflex in 3 min after propofol administration. When 'success', the next patient will receive the same dose(in 18/19 probability) or 0.125 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the next patient will receive 0.125 mg/kg higher dose of propofol at induction period.

Conditions

Anesthesia

Keywords

propofol; midazolam; remifentanil; combination; synergic; pharmacodynamics; Loss of consciousness

Outcome Measures

Primary Outcomes (2)

• Loss of verbal response and eyelash reflex

  Checking verbal response by verbal stimulation (response or no response).

  3 minutes after propofol administration

• Loss of eyelash reflex

  Checking reflex by palpation of the levator palpebrae (reflex or no reflex).

  3 minutes after propofol administration

Secondary Outcomes (2)

• Mean blood pressure

  baseline, propofol administration time (Just after finishing monitoring on the patient in P group, 5 minutes after remifentanil infusion start in PR and PMR group), 1 minute, 2 minutes and 3 minutes after propofol administration

• Heart rate

  baseline, propofol administration time (Just after finishing monitoring on the patient in P group, 5 minutes after remifentanil infusion start in PR and PMR group), 1 minute, 2 minutes and 3 minutes after propofol administration

Study Arms (3)

Group P

ACTIVE COMPARATOR

Induction with propofol bolus. Dose will be started at 0.5 mg/kg and will be adjusted as described in summary.

Drug: Propofol

Group PR

ACTIVE COMPARATOR

Induction with propofol and remifentanil. Remifentanil infusion 0.125 mcg/kg/min for 5 min followed by propofol bolus Propofol dose will be started at 0.5 mg/kg and will be adjusted as described in summary.

Drug: Propofol; Drug: Remifentanil

Group PMR

ACTIVE COMPARATOR

Induction with propofol, midazolam and remifentanil. Remifentanil infusion 0.125 mcg/kg/min for 5 min followed by midazolam 0.015 mg/kg bolus 1 min after remifentanil infusion start and propofol bolus administration. Propofol dose will be started at 0.5 mg/kg and will be adjusted as described in summary.

Drug: Propofol; Drug: Remifentanil; Drug: Midazolam

Interventions

Propofol DRUG

Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.

Also known as: Fresofol

Group P; Group PMR; Group PR

Remifentanil DRUG

Remifentanil 0.125 mcg/kg/min infusion for 5 min before propofol administration.

Also known as: Ultiva

Group PMR; Group PR

Midazolam DRUG

Remifentanil 0.125 mcg/kg/min infusion for 5 min before propofol administration followed by midazolam 0.015 mg/kg administration 1 min after remifentanil infusion start.

Group PMR

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• The elderly patients (over 65 years old) who are scheduled to undergo general anesthesia.

You may not qualify if:

• ASA class (American Society of Anesthesiologist physical status classification) IV or higher
• Patients with history of allergy or side effects on propofol, remifentanil, midazolam
• BMI (body mass index) less than 20 or higher than 30
• Patients taking sedatives or hypnotic agents.

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, Korea, 135-720, South Korea

RECRUITING

Related Publications (1)

• Conway DH, Hasan SK, Simpson ME. Target-controlled propofol requirements at induction of anaesthesia: effect of remifentanil and midazolam. Eur J Anaesthesiol. 2002 Aug;19(8):580-4. doi: 10.1017/s0265021502000935.

  PMID: 12200947 BACKGROUND

MeSH Terms

Conditions

Unconsciousness

Interventions

Propofol; Remifentanil; Midazolam

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dong Woo Han, MD,PhD

  Gangnam Severance Hospital

  STUDY CHAIR

Central Study Contacts

Jiwon An, MD

CONTACT

82-2-2019-3520

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 29, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

KR (1)