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Impact of Dexmedetomidine on Sleep Quality

NCT03117790 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-02-10

No results posted yet for this study

Summary

Sleep disturbances frequently occur in elderly patients after major surgery; and their occurrence are associated with worse outcomes including increased incidence of delirium. Previous studies showed that, for elderly patients admitted to the ICU after non-cardiac surgery, low-dose dexmedetomidine infusion improved to some degree the quality of sleep and reduced the incidence of delirium. The investigators hypothesize that, for elderly patients after major non-cardiac surgery, dexmedetomidine supplemented analgesia can also improve the sleep quality. The purpose of this randomized controlled pilot study is to investigate the impact of dexmedetomidine supplemented analgesia on the sleep quality in elderly patients after major non-cardiac surgery.

Conditions

  • Elderly
  • Surgery
  • Analgesia
  • Dexmedetomidine
  • Complication,Postoperative
  • Sleep Quality

Interventions

DRUG

Dexmedetomidine

Morphine (0.5 mg/ml, in a total volume of 160 ml) is used for patient-controlled analgesia. Dexmedetomidine (200 ug) is added to the formula of patient-controlled analgesia. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time from 6 to 8 minutes.

DRUG

Placebo

Morphine (0.5 mg/ml, in a total volume of 160 ml) is used for patient-controlled analgesia. Placebo (normal saline) is added to the formula of patient-controlled analgesia. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time from 6 to 8 minutes.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD,PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2020-01-16
Completion
2020-02-18

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03117790 on ClinicalTrials.gov