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Elderly PatientsCSUHAPMNCT01851005

Effect of Dexmedetomidine on Recovery Profiles of Elderly Patients

A study testing Dexmedetomidine, Sevoflurane and Propofol and Remifentanil in people with Elderly Patients and Anesthesia, run by Chosun University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Dexmedetomidine, Sevoflurane and Propofol and Remifentanil
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteSouth Korea
Study dates
May 2013to Feb 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • ASA I-II
  • Age > 65
  • Elective surgery

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Chosun University Hospital

    Gwangju, 501-717

Other trials in South Korea

About this study

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.

Read the 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.

Being tested
Dexmedetomidine, Sevoflurane, Propofol and Remifentanil, Normal saline, Rocuronium
Keywords
Dexmedetomidine, Anesthesia, Recovery profile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Precedex

    Infusion of dexmedetomidine (0.4 ug/kg/hr)

  • SevofluraneDrug

    Also called Sevorane

    Control Vol% to maintain BIS 40~45

  • Propofol and RemifentanilDrug

    Also called Total intravenous anesthesia

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

  • Normal salineDrug

    Also called Placebo

    Use as placebo

  • RocuroniumDrug

    Also called Muscle relaxation during general anesthesia

    0.8 mg/kg for induction

Study groups in NCT01851005
Study groupRoleWhat they receive
Group 1Placebo comparatorGeneral anesthesia with sevoflurane. Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.
Receives: Drug: Sevoflurane; Drug: Normal saline; Drug: Rocuronium
Group 2Placebo comparatorGeneral anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.
Receives: Drug: Propofol and Remifentanil; Drug: Normal saline; Drug: Rocuronium
Group 3ExperimentalGeneral anesthesia with sevoflurane. Infusion of dexmedetomidine (0.4 ug/kg/hr) during anesthesia. Administer rocuronium 0.8 mg/kg for induction.
Receives: Drug: Dexmedetomidine; Drug: Sevoflurane; Drug: Rocuronium
Group 4ExperimentalGeneral 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.
Receives: Drug: Dexmedetomidine; Drug: Propofol and Remifentanil; Drug: Rocuronium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recovery time (1)

    Time to eye opening.

    Measured: At the end of surgery and anesthesia, an expected average of 15 minutes

Secondary outcomes (1)
  1. Ricker scale

    Time to eye opening Ricker sedation-agitated scale in PACU (At the times of arrival and leaving postanesthetic care unit)

    Measured: About 5 minutes after end of surgery and anesthesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01851005
Sponsor's protocol ID
DEX-RP
Acronym
CSUHAPM
Status last verified
Mar 2014
First submitted
30 Apr 2013
Last updated
19 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • Juvin P, Servin F, Giraud O, Desmonts JM. Emergence of elderly patients from prolonged desflurane, isoflurane, or propofol anesthesia. Anesth Analg. 1997 Sep;85(3):647-51. doi: 10.1097/00000539-199709000-00029.

    PubMed 9296424
  • Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.

    PubMed 20705788
  • Tei M, Ikeda M, Haraguchi N, Takemasa I, Mizushima T, Ishii H, Yamamoto H, Sekimoto M, Doki Y, Mori M. Risk factors for postoperative delirium in elderly patients with colorectal cancer. Surg Endosc. 2010 Sep;24(9):2135-9. doi: 10.1007/s00464-010-0911-7. Epub 2010 Feb 23.

    PubMed 20177939
  • Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2.

    PubMed 16670111
  • Kim DJ, Kim SH, So KY, Jung KT. Effects of dexmedetomidine on smooth emergence from anaesthesia in elderly patients undergoing orthopaedic surgery. BMC Anesthesiol. 2015 Oct 7;15:139. doi: 10.1186/s12871-015-0127-4.

    PubMed 26446479

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine, Sevoflurane and Propofol and Remifentanil in people with Elderly Patients and Anesthesia, run by Chosun University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery time (1) (time frame: At the end of surgery and anesthesia, an expected average of 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01851005, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.

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