Dexmedetomidine Supplemented Analgesia and Incidence of Postoperative Delirium

NCT03012984 | Completed DMC

• 1 other identifier: 2016-10
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 12

Brief Summary

Delirium is a frequently occurred cerebral complication in elderly patients after surgery, and its occurrence is associated with worse outcomes. Sleep disturbances is considered to be one of the most important risk factors of postoperative delirium. Previous studies showed that, for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine infusion improved the quality of sleep and decreased the incidence of delirium. The investigators hypothesize that, for elderly patients after cancer surgery, dexmedetomidine supplemented analgesia can also decrease the incidence of delirium, possibly by improving sleep quality. The purpose of this multicenter, randomized controlled trial is to investigate the impact of dexmedetomidine supplemented analgesia on the incidence of delirium in elderly patients after cancer surgery.

Conditions

Elderly; Surgery; Analgesia; Dexmedetomidine; Complication, Postoperative; Delirium

Keywords

elderly; surgery; analgesia; dexmedetomidine; delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium within 5 days after surgery

  Incidence of delirium within 5 days after surgery

  During the first 5 days after surgery

Secondary Outcomes (6)

• Daily prevalence of delirium during the first 5 postoperative days

  During the first 5 postoperative days

• Length of stay in hospital after surgery

  Up to 30 days after surgery

• Incidence of non-delirium complications after surgery

  Up to 30 days after surgery

• 30-day all-cause mortality after surgery

  At the time of 30 days after surgery

• Quality of life in survival patients on the 30th day after surgery

  On the 30th day after surgery

Other Outcomes (4)

• Richmond Agitation-Sedation Scale (RASS) score during the first 5 days after surgery

  During the first 5 days after surgery

• Cumulative morphine consumption during the first 3 days after surgery

  During the first 3 days after surgery

• Numeric Rating Scale (NRS) pain score during the first 5 days after surgery

  During the first 5 days after surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Dexmedetomidine supplemented morphine analgesia will be provided for patients in this group in the form of patient-controlled intravenous analgesia. The formula contains a mixture of morphine (0.5 mg/ml) and dexmedetomidine (1.25 ug/ml), diluted with normal saline to a total volume of 160 ml. 5-HT3 receptor antagonist is added when necessary. 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: Dexmedetomidine supplemented morphine analgesia

Control group

PLACEBO COMPARATOR

Morphine analgesia will be provided for patients in this group in the form of patient-controlled intravenous analgesia. The formula contains morphine (0.5 mg/ml), diluted with normal saline to a total volume of 160 ml. 5-HT3 receptor antagonist is added when necessary. 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: Morphine analgesia

Interventions

Dexmedetomidine supplemented morphine analgesia DRUG

Patients in this group will receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is a mixture of dexmedetomidine (1.25 ug/ml) and morphine (0.5 mg/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml each time and a lockout time from 6 to 8 minutes according to patients' condition.

Dexmedetomidine group

Morphine analgesia DRUG

Patients in this group will receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is morphine (0.5 mg/ml) diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml each time and a lockout time from 6 to 8 minutes according to patients' condition.

Control 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, \< 90 years;
• Scheduled to undergo curative resection for primary solid organ cancer under general anesthesia, with an expected duration of surgery \>=2 hours;
• Planned to use patient-controlled intravenous analgesia after surgery;
• Provide written informed consent.

You may not qualify if:

• Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;
• Preoperative radio- or chemotherapy;
• Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
• Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or a STOP-Bang score \>= 3 and serum HCO3- \>= 28 mmol/L);
• Brain trauma 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) or severe renal dysfunction (requirement of renal replacement therapy before surgery);
• ASA classification \>= IV.

Sponsors & Collaborators

• Guizhou Provincial People's Hospital: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Tianjin Hospital of ITCWM-Nankai Hospital: collaborator
• Chongqing University Fuling Hospital: collaborator
• The Third Central Hospital of Tianjin: collaborator
• Xiyuan Hospital of China Academy of Chinese Medical Sciences: collaborator
• Peking University First Hospital: lead
• Qingdao Municipal Hospital: collaborator
• The Second Affiliated Hospital of Air Force Medical University: collaborator
• Peking University International Hospital: collaborator
• Affiliated Hospital of Hebei University: collaborator
• Shanxi Province Cancer Hospital: collaborator

Study Sites (12)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

Location

Peking University International Hospital

Beijing, Beijing Municipality, 102206, China

Location

Chongqing University Fuling Hospital

Chongqing, Chongqing Municipality, 408099, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China

Location

Affiliated Hospital of Hebei University

Baoding, Hebei, 050031, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

The Second Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, 710038, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, 266011, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030013, China

Location

Tianjin Hospital of ITCWM-Nankai Hospital

Tianjin, Tianjin Municipality, 300100, China

Location

The Third Central Hospital of Tianjin

Tianjin, Tianjin Municipality, 300170, China

Location

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MeSH Terms

Conditions

Agnosia; Postoperative Complications; Delirium

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Confusion; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dong-Xin Wang, MD,PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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

Study Record Dates

• First Submitted: December 31, 2016
• First Posted: January 6, 2017
• Study Start: January 6, 2017
• Primary Completion: May 12, 2022
• Study Completion: June 11, 2022
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)