Effect of Dexmedetomidine on Recovery Profiles of Elderly Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-02-28

Brief Summary

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Emergence of elderly patients from anesthesia may face with cognitive dysfunction or agitation such as delirium. There are reports that using dexmedetomidine as a adjuvant for general anesthesia decreased emergence-agitation in children and dexmedetomidine may be used for treating deliriums. Thus, we thought that dexmedetomidine as a adjuvant agent may be a help to smooth emergence from anesthesia in elderly.

The aims of this study were to investigate the recovery characteristics (time to recovery of consciousness (ROC) and recovery, bispectral index (BIS) values at ROC and orientation, and Ricker sedation-agitated scale at the postanesthetic care unit) and safety (vital signs during and after administration of dexmedetomidine) of dexmedetomidine in elderly patients undergoing elective surgery.

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Detailed Description

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Purpose: The aims of this study were to investigate the recovery characteristics (time to recovery of consciousness (ROC) and recovery, bispectral index (BIS) values at ROC and orientation, and Ricker sedation-agitated scale at the postanesthetic care unit) and safety (vital signs during and after administration of dexmedetomidine) of dexmedetomidine in elderly patients undergoing elective surgery.

Hypothesis: Dexmedetomidine as a adjuvant agent may be a help to smooth emergence from anesthesia in elderly.

Objectives: Patients who are scheduled to undergo elective surgery, American society of anesthesiologist class (ASA) I-II, aged over 65 years, are randomly allocated into six groups.

* Group 1: general anesthesia with sevoflurane only (placebo: normal saline)
* Group 2: general anesthesia with propofol and remifentanil (total intravenous anesthesia) only (placebo: normal saline)
* Group 3: general anesthesia with sevoflurane and adjuvant dexmedetomidine
* Group 4: general anesthesia with propofol and remifentanil (total intravenous anesthesia), and adjuvant dexmedetomidine

Research Method: Once in the operating room, patients were monitored with electrocardiography, non invasive blood pressure, pulse oximetry (Datex-Ohmeda S/5, Planar Systems, Inc., Beaverton, OR, USA) and BIS (Aspect 2000, Aspect Medical Systems, Inc., Newton, MA, USA).

In the group 1 and group 3, anesthesia was induced with propofol (2mg/kg) and followed by administering rocuronium 0.6 mg/kg. After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:2), and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 45 mmHg. The concentrations of sevoflurane was adjusted for maintain BIS score between 40 and 45.

In the group 2 and group 4, anesthesia was induced and maintained with total intravenous anesthesia using propofol and remifentanil. Effective site concentration of propofol and remifentanil were adjusted for maintain BIS between 40 and 45 and maintain changes of vital sign between 20% of baseline value.

In the group 3 and group 4, dexmedetomidine was administered (0.4 ug/kg/hr) during surgery. Instead, in the group 1 and group 2, normal saline was administered with same rate as a placebo.

The concentrations of sevoflurane was measured continuously using an infrared anesthetic gas analyzer (Datex-Ohmeda S/5, Planar Systems, Inc., Beaverton, OR, USA) and the effect site concentration of propofol and remifentanil also measured with target controlled infuser (Orchestra® Base Primea, Fresenius-Vial, France) during surgery.

After the end of surgery, all anesthetics or dexmedetomidine was discontinued and the time to recovery BIS score until 60, 70, and 80 were measured. Patients were asked to open their eyes and the time of eye opening were measured. After the eye opening, reversal agent was administered and the patients were transferred to postanesthetic care unit (PACU).

After arrival on PACU, blood pressure, heart rate, and Ricker sedation-agitated scale were measure every 5 minutes. When the Ricker sedation-agitated scale became 4, patients were transferred to ward, and the time of staying in postanesthetic care unit were measured.

The incidence of nausea, vomiting, hypotension, hypertension, bradycardia, and tachycardia was measured during surgery and staying in postanesthetic care unit.

All participants will be followed for the duration of surgery and postanesthetic care unit stay, an expected average of 1 day.

Statistical Analysis: All data are expressed as mean ± standard deviation. Recovery profiles (time to recovery of consciousness (ROC) and recovery, BIS values at ROC and orientation, and Ricker sedation-agitated scale at the postanesthetic care unit) were analyzed by paired t-test. And the incidence of nausea/vomiting, hypotension, hypertension, bradycardia, and tachycardia was analyzed by Chi-square test.

Conditions

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Elderly Patients Anesthesia Emergence From Anesthesia Effects of Dexmedetomidine Recovery From Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

General anesthesia with sevoflurane. Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.

Group Type PLACEBO_COMPARATOR

Sevoflurane

Intervention Type DRUG

Control Vol% to maintain BIS 40\~45

Normal saline

Intervention Type DRUG

Use as placebo

Rocuronium

Intervention Type DRUG

0.8 mg/kg for induction

Group 2

General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.

Group Type PLACEBO_COMPARATOR

Propofol and Remifentanil

Intervention Type DRUG

Control effect site concentration for maintain BIS 40\~45 and changes of vital signs within 20%.

Normal saline

Intervention Type DRUG

Use as placebo

Rocuronium

Intervention Type DRUG

0.8 mg/kg for induction

Group 3

General anesthesia with sevoflurane. Infusion of dexmedetomidine (0.4 ug/kg/hr) during anesthesia. Administer rocuronium 0.8 mg/kg for induction.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Infusion of dexmedetomidine (0.4 ug/kg/hr)

Sevoflurane

Intervention Type DRUG

Control Vol% to maintain BIS 40\~45

Rocuronium

Intervention Type DRUG

0.8 mg/kg for induction

Group 4

General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of dexmedetomidine (0.4 ug/kg/hr) during surgery. Administer rocuronium 0.8 mg/kg for induction.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Infusion of dexmedetomidine (0.4 ug/kg/hr)

Propofol and Remifentanil

Intervention Type DRUG

Control effect site concentration for maintain BIS 40\~45 and changes of vital signs within 20%.

Rocuronium

Intervention Type DRUG

0.8 mg/kg for induction

Interventions

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Dexmedetomidine

Infusion of dexmedetomidine (0.4 ug/kg/hr)

Intervention Type DRUG

Sevoflurane

Control Vol% to maintain BIS 40\~45

Intervention Type DRUG

Propofol and Remifentanil

Control effect site concentration for maintain BIS 40\~45 and changes of vital signs within 20%.

Intervention Type DRUG

Normal saline

Use as placebo

Intervention Type DRUG

Rocuronium

0.8 mg/kg for induction

Intervention Type DRUG

Other Intervention Names

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Precedex Sevorane Total intravenous anesthesia Placebo Muscle relaxation during general anesthesia

Eligibility Criteria

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Inclusion Criteria

* ASA I-II
* Age \> 65
* Elective surgery

Exclusion Criteria

* Patients with severe heart disease with New York Heart Association class \> III
* Patients with severe arrhythmia
* Patients with uncontrolled hypertension or hypotension
* Patients with hemodynamic unstably
* Patients with hypersensitivity with drugs
* Patients with cognitive deficiency, dementia, or delirium
* Patients with hepatic or renal compromise
* Patients with infective disease

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes