Dexmedetomidine Supplemented Analgesia in Patients at High-risk of Obstructive Sleep Apnea

NCT04608331 | Completed Phase 4 DMC

• 1 other identifier: 2020-189
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a common sleep disturbance that can cause intermittent hypoxia, hypercapnia, and sleep structure disorders. The presence of OSA is associated with worse outcomes after surgery including increased incidence of complications. High-flow nasal cannula (HFNC) therapy can improve oxygenation of OSA patients by maintaining a certain positive pressure in the nasopharyngeal cavity. Previous studies showed that, dexmedetomidine supplemented analgesia can improve sleep quality and pain relief. The investigators hypothesize that, for high-risk OSA patients following major non-cardiac surgery with HFNC therapy, dexmedetomidine supplemented analgesia can improve sleep quality. The purpose of this pilot randomized controlled trial is to investigate the impact of dexmedetomidine supplemented analgesia on sleep quality in high-risk OSA patients after major non-cardiac surgery.

Conditions

Obstructive Sleep Apnea; Analgesia; Dexmedetomidine; High-flow Nasal Cannula; Sleep Quality

Keywords

Obstructive Sleep Apnea; Analgesia; Dexmedetomidine; High-flow nasal cannula; Sleep quality

Outcome Measures

Primary Outcomes (1)

• The percentage of non-rapid eye movement stage 2 (N2) sleep.

  Calculated according to polysomnographic monitoring results.

  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)

• Total sleep duration.

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

• Sleep efficiency.

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

• Duration of non-rapid eye movement stage 1 (N1) sleep.

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

• Percentage of non-rapid eye movement stage 1 (N1) sleep.

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

• Duration of non-rapid eye movement stage 2 (N2) 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 (11)

• Sedation level

  Up to 5 days after surgery.

• Cumulative morphine consumption

  Up to 5 days after surgery.

• Pain intensity

  Up to 5 days after surgery.

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Patient-controlled analgesia is established with morphine (0.5 mg/ml) and dexmedetomidine (1.25 microgram/ml) in a total volume of 160 ml. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h. Patient-controlled analgesia is provided for at least 24 hours after surgery.

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

Patient-controlled analgesia is established with morphine (0.5 mg/ml) in a total volume of 160 ml. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h. Patient-controlled analgesia is provided for at least 24 hours after surgery.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours. The pump is established with morphine (0.5 mg/ml) and dexmedetomidine (1.25 microgram/ml), in a total volume of 160 ml normal saline, and programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate of 1 ml/h.

Also known as: Dexmedetomidine hydrochloride

Dexmedetomidine group

Placebo DRUG

Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours. The pump is established with morphine (0.5 mg/ml), in a total volume of 160 ml normal saline, and programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate of 1 ml/h.

Also known as: Normal saline

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 years but \<=80 years;
• At high-risk of obstructive sleep apnea (a STOP-Bang score ≥3 combined with a serum bicarbonate ≥28 mmol/ L), but does not regularly receive continuous positive airway pressure (CPAP) therapy;
• Scheduled to undergo major noncardiac surgery under general anesthesia, with an expected duration of \>=1 hours and planned to use patient-controlled intravenous analgesia (PCIA) after surgery.

You may not qualify if:

• Diagnosed as central sleep apnea syndrome;
• Preoperative history of severe central nervous system diseases (epilepsy, parkinsonism, intracranial tumor, craniocerebral trauma) or neuromuscular disorders (myasthenia gravis);
• History of schizophrenia or other mental disorders, or antidepressant or anxiolytic therapy within 3 month before surgery;
• Inability to communicate in the preoperative period because of coma, profound dementia, deafness or language barriers;
• History of drug or alcohol dependence, or sedative or hypnotic therapy within 1 month before surgery;
• Contraindications to HFNC therapy (e.g. mediastinal emphysema, shock, cerebrospinal fluid leakage, nasosinusitis, otitis media, glaucoma);
• Severe tracheal or pulmonary disease (e.g. bullous lung disease, pneumothorax, tracheal fistula);
• 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); severe heart dysfunction (preoperative New York Heart Association functional classification ≥3 or left ventricular ejection fraction \<30%); ASA classification IV or above; or expected survival \<24 hours after surgery;
• Preoperative use of CPAP or HFNC therapy;
• Expected intensive care unit (ICU) admission with tracheal intubation after surgery;
• Refuse to participate in this study;
• Other conditions that are considered unsuitable for study participation.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Dong-Xin Wang

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (20)

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  PMID: 39416950 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Agnosia; Sleep Initiation and Maintenance Disorders

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

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

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 29, 2020
• Study Start: January 29, 2021
• Primary Completion: August 17, 2022
• Study Completion: September 20, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)