Effect of Dexmedetomidine on Recovery Profiles of Elderly Patients (CSUHAPM)

March 18, 2014 updated by: Ki Tae Jung, Chosun University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group 1
General anesthesia with sevoflurane. Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.
Drug: Sevoflurane
Control Vol% to maintain BIS 40~45
Other Names:
  • Sevorane
Drug: Normal saline
Use as placebo
Other Names:
  • Placebo
Drug: Rocuronium
0.8 mg/kg for induction
Other Names:
  • Muscle relaxation during general anesthesia
Placebo Comparator: 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.
Drug: Normal saline
Use as placebo
Other Names:
  • Placebo
Drug: Rocuronium
0.8 mg/kg for induction
Other Names:
  • Muscle relaxation during general anesthesia
Drug: Propofol and Remifentanil
Control effect site concentration for maintain BIS 40~45 and changes of vital signs within 20%.
Other Names:
  • Total intravenous anesthesia
Experimental: Group 3
General anesthesia with sevoflurane. Infusion of dexmedetomidine (0.4 ug/kg/hr) during anesthesia. Administer rocuronium 0.8 mg/kg for induction.
Drug: Sevoflurane
Control Vol% to maintain BIS 40~45
Other Names:
  • Sevorane
Drug: Rocuronium
0.8 mg/kg for induction
Other Names:
  • Muscle relaxation during general anesthesia
Drug: Dexmedetomidine
Infusion of dexmedetomidine (0.4 ug/kg/hr)
Other Names:
  • Precedex
Experimental: 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.
Drug: Rocuronium
0.8 mg/kg for induction
Other Names:
  • Muscle relaxation during general anesthesia
Drug: Propofol and Remifentanil
Control effect site concentration for maintain BIS 40~45 and changes of vital signs within 20%.
Other Names:
  • Total intravenous anesthesia
Drug: Dexmedetomidine
Infusion of dexmedetomidine (0.4 ug/kg/hr)
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery time (1)
Time Frame: At the end of surgery and anesthesia, an expected average of 15 minutes
Time to eye opening.
At the end of surgery and anesthesia, an expected average of 15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ricker scale
Time Frame: About 5 minutes after end of surgery and anesthesia
Time to eye opening Ricker sedation-agitated scale in PACU (At the times of arrival and leaving postanesthetic care unit)
About 5 minutes after end of surgery and anesthesia

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: Participants will be followed for the duration of postanesthetic care unit stay, an expected average of 1 hour
The incidence of nausea, vomiting, hypotension, hypertension, bradycardia, and tachycardia (During surgery and staying in postanesthetic care unit)
Participants will be followed for the duration of postanesthetic care unit stay, an expected average of 1 hour
Recovery time (2)
Time Frame: At the end of surgery and anesthesia, an expected average of 15 minutes
Time to recover BIS 60, 70, and 80.
At the end of surgery and anesthesia, an expected average of 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chosun University Hospital

Investigators

  • Study Chair: Ki Tae Jung, M.D., Department of Anesthesiology and Pain medicine School of Medicine, Chosun University

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

April 30, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 18, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEX-RP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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