Dexmedetomidine Supplemented Analgesia and Long-term Survival After Cancer Surgery

Surgery Clinical Trial

Official title:

Impact of Dexmedetomidine Supplemented Analgesia on Long-term Survival in Elderly Patients After Cancer Surgery: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03012971
• Other study ID #: 2016-10-LT
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 6, 2017
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A majority of the elderly patients undergo surgery for malignant tumors. For these patients, postoperative tumor recurrence and metastasis are main factors that worsen the quality of life and shorten the duration of survival. Perioperative immune function is a key element that influences postoperative tumor recurrence and metastasis; but it is subject to the impacts of many factors. Studies showed that elevated cortisol level and inflammation provoked by surgical stress result in suppression of immune function, whereas dexmedetomidine alleviates the elevated cortisol level and inhibit excessive inflammation; high-dose opioids inhibit the immune function and increase the invasiveness of tumor cells, whereas dexmedetomidine reduces the consumption of opioids during perioperative period; postoperative sleep disturbances also impair immune function, whereas dexmedetomidine improves sleep quality in patients after surgery; occurrence of postoperative delirium is associated with increased mortality, whereas dexmedetomidine reduces delirium incidence. The investigators hypothesize that dexmedetomidine supplemented analgesia in elderly patients after cancer surgery may improve the long-term outcomes, possibly by relieving stress and inflammatory response, improving analgesic efficacy and sleep quality, and reducing delirium incidence.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: May 2024
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age >= 65 years, < 90 years;

• Scheduled to undergo surgery 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.

Exclusion Criteria:

• 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);

• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dexmedetomidine supplemented morphine analgesia
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.
• Morphine analgesia
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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (14)

Lead Sponsor

Collaborator

Peking University First Hospital

Affiliated Hospital of Hebei University, Beijing Chao Yang Hospital, Beijing Ditan Hospital, Beijing Shijitan Hospital, Capital Medical University, Beijing Tsinghua Chang Gung Hospital, Guizhou Provincial People's Hospital, Peking University International Hospital, Qingdao Municipal Hospital, Shanxi Provincial Cancer Hospital, The Second Affiliated Hospital of Air Force Medical University, The Third Xiangya Hospital of Central South University, Tianjin Hospital of ITCWM-Nankai Hospital, Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival after surgery	Overall survival after surgery	Up to 7 years after surgery
Secondary	Recurrence-free after surgery	Recurrence-free after surgery	Up to 7 years after surgery
Secondary	Cancer-specific survival after surgery	Cancer-specific survival after surgery	Up to 7 years after surgery
Secondary	Event-free survival after surgery	Event-free survival after surgery	Up to 7 years after surgery
Secondary	Cognitive function of survival patients at 2 years after surgery	Cognitive function was assessed with Telephone Interview for Cognitive Function-Modified (TICS-M)	At the end of 2 years after surgery
Secondary	Quality of life of survival patients at 2 years after surgery	Quality of life was assessed with World Health Organization Quality of Life-Bref (WHOQOL-BREF)	At the end of 2 years after surgery