Dexmedetomidine Supplemented Analgesia and Long-term Survival After Cancer Surgery

NCT03012971 | Completed DMC

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

Brief Summary

A majority of the elderly patients undergo surgery for malignant tumors. For these patients, postoperative tumor recurrence and metastasis are main factors that worsen long-term outcomes. The investigators hypothesize that dexmedetomidine supplemented analgesia in elderly patients after cancer surgery may help to maintain immune function and improve long-term outcomes, possibly by relieving stress and inflammatory response, improving analgesic efficacy and sleep quality, and reducing delirium incidence.

Conditions

Elderly; Surgery; Analgesia; Dexmedetomidine; Long-term Outcome

Keywords

Elderly; Surgery; Analgesia; Dexmedetomidine; Long-term outcome

Outcome Measures

Primary Outcomes (1)

• Overall survival after surgery

  Overall survival is defined as time interval from index surgery to all-cause death after surgery.

  Up to 7 years after surgery

Secondary Outcomes (5)

• Recurrence-free survival after surgery

  Up to 7 years after surgery

• Cancer-specific survival after surgery

  Up to 7 years after surgery

• Event-free survival after surgery

  Up to 7 years after surgery

• Cognitive function of survival patients at 1 and 2 years after surgery

  At the end of 1 and 2 years after surgery

• Quality of life of survival patients at 1 and 2 years after surgery

  At the end of 1 and 2 years after surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Dexmedetomidine supplemented morphine analgesia is 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 is 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 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 at each time and a lockout time from 6 to 8 minutes.

Dexmedetomidine group

Morphine analgesia DRUG

Patients in this group 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 at each time and a lockout time from 6 to 8 minutes.

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

• Peking University First Hospital: lead
• Affiliated Hospital of Hebei University: collaborator
• Qingdao Municipal Hospital: collaborator
• The Second Affiliated Hospital of Air Force Medical University: collaborator
• Peking University International Hospital: collaborator
• Guizhou Provincial People's Hospital: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Shanxi Province Cancer Hospital: 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

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 , , China, Contact:

Beijing, Beijing Municipality, 102206, China

Location

Chongqing University Fuling Hospital

Chongqing, Chongqing Municipality, 408099, China

Location

Guizhou Provincial People's Hospital , China, Contact:

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 , , China, Contact:

Qingdao, Shandong, 266011, China

Location

Shanxi Provincial Cancer Hospital , China, Contact:

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

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 and Critical Care Medicine

Study Record Dates

• First Submitted: December 31, 2016
• First Posted: January 6, 2017
• Study Start: January 6, 2017
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)