Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients

Intraoperative Application of Dexmedetomidine on the Incidence of Postoperative Delirium and Quality of Recovery in Geriatric Patients Undergoing Major Surgery

Postoperative agitation (hyperactive delirium) is common following major surgery(incidence was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine is useful on reducing postoperative delirium. The hypothesis of present study: intraoperative application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than placebo for reducing of early postoperative delirium and increase postoperative quality of recovery within 24 postoperative hours.

Study Overview

• Status: Unknown
• Conditions: Delirium, Postoperative
• Intervention / Treatment: Drug: Placebo; Drug: Dexmedetomidine

Detailed Description

After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of adult patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I-III, undergoing selective major surgery under general anesthesia. All the patients were randomly assigned to receive dexmedetomidine or placebo during the operation. The primary outcome measure was postoperative delirium assessed by Nursing Delirium Screening Scale (Nu-DESC) every 8 hours within 24 postoperative hours. The secondary outcome was length of postanesthesia care unit (PACU) stay,postoperative hospital length of stay, hemodynamic parameters, the incidence of postoperative nausea and vomiting, and quality of recovery determined by quality of recovery (QOR40; maximum score 200)and Post-operative Quality Recovery Scale (PQRS) in the first 24 h after surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Wei Mei, M.D.; Phone Number: 00862783663173; Email: wmei@tjh.tjmu.edu.cn
      • Contact: Yuke Tian, M.D.; Phone Number: 00862783663173; Email: yktian@tjh.tjmu.edu.cn
      • Principal Investigator: Wei Mei, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status class I-III
• Aged 60 years or above
• Elective major surgery under general anesthesia

Exclusion Criteria:

• ASA-PS>=IV
• Aged under 60 yr old
• Body mass index (BMI) >30
• Neurologic disease
• Cardiac surgery and neurologic surgery
• Anticonvulsant drugs
• Chronic analgesics intake
• Participating in the investigation of another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm P; Placebo infusion	Drug: Placebo; Placebo (saline) iv. during the operation and stoped 30min before end of the surgery
EXPERIMENTAL: Arm D; Dexmedetomidine infusion	Drug: Dexmedetomidine; Dexmedetomidine 0.1~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative delirium	Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours	every 8 hours within 24 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of PACU stay	Length of PACU stay (min)	during PACU stay
hemodynamic parameters	Heart frequency, systolic blood pressure, diastolic blood pressure	every 5min during operation and every 15min during PACU stay
incidence of postoperative nausea and vomiting	incidence of postoperative nausea and vomiting	24 postoperative hours
quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)	quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)	24 postoperative hours
Postoperative delirium	Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours	1st, 2nd, 3rd postoperative days
Postoperative Stroke	Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score).	1st, 2nd, 3rd, 7th postoperative days

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Chair: Yuke Tian, M.D., Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; Study Director: Chuanhan Zhang, MD., Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ANTICIPATED): June 1, 2014

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (ESTIMATE): January 26, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 20, 2013
• Last Update Submitted That Met QC Criteria: November 19, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Adult Patients; Delirium; General Anesthesia; Elective Major Surgery
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: TIHMZK02004