Impact of Dexmedetomidine on Sleep Quality

NCT03117790 | Completed Phase 4 DMC

• 1 other identifier: DEXsleep
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

elderly; surgery; analgesia; dexmedetomidine; sleep quality

Outcome Measures

Primary Outcomes (1)

• The percentage of stage N2 sleep

  Determined by polysomnographic monitoring

  During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery)

Secondary Outcomes (10)

• The duration of stage N1 sleep

  During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery)

• The percentage of stage N1 sleep

  During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery)

• The duration of stage N2 sleep

  During the night after surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery)

• The duration of stage N3 sleep

  During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery)

• The percentage of stage N3 sleep

  During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery)

Other Outcomes (10)

• Pain intensity

  Up to the fifth day after surgery

• Subjective sleep quality

  Up to the fifth day after surgery

• Sedation level

  Up to the fifth day after surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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. Patient-controlled analgesia is provided during the first 3 days after surgery.

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

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. Patient-controlled analgesia is provided during the first 3 days after surgery.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

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.

Also known as: Dexmedetomidine supplemented morphine analgesia

Dexmedetomidine group

Placebo DRUG

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.

Also known as: Morphine analgesia

Placebo group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \>= 65 years
• Scheduled to undergo elective non-cardiac major surgery (with expected duration \>= 2 hours) under general anesthesia
• Transferred to general ward with a patient-controlled intravenous analgesia pump after surgery.

You may not qualify if:

• Refuse to participate
• Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis
• Patients with preoperative sleep disorders (accepted sedatives or hypnotics within 1 month before surgery) or the STOP-BANG Questionnaire score is 3 or higher
• Inability to communicate in the preoperative period because of coma, profound dementia or language barrier
• Brain injury or neurosurgery
• Preoperative left ventricular ejection fraction \< 30%, sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker
• Severe hepatic dysfunction (Child-Pugh class C); Severe renal dysfunction (requirement of renal replacement therapy before surgery); ASA classification IV or unlikely to survive for more than 24 hours after surgery
• Patients recruited in other studies
• Other conditions that are considered unsuitable for study participation

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (19)

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• Zhang ZF, Su X, Zhao Y, Zhong CL, Mo XQ, Zhang R, Wang K, Zhu SN, Shen YE, Zhang C, Wang DX. Effect of mini-dose dexmedetomidine supplemented intravenous analgesia on sleep structure in older patients after major noncardiac surgery: A randomized trial. Sleep Med. 2023 Feb;102:9-18. doi: 10.1016/j.sleep.2022.12.006. Epub 2022 Dec 20.

  PMID: 36587547 DERIVED

MeSH Terms

Conditions

Agnosia; Postoperative Complications; Sleep Initiation and Maintenance Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dong-Xin Wang, MD,PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman,Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: April 2, 2017
• First Posted: April 18, 2017
• Study Start: June 26, 2017
• Primary Completion: January 16, 2020
• Study Completion: February 18, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)