ElderlyNCT03012971
Dexmedetomidine Supplemented Analgesia and Long-term Survival After Cancer Surgery
A study testing Dexmedetomidine supplemented morphine analgesia and Morphine analgesia in people with Elderly and Surgery, run by Peking University First Hospital at 12 sites in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- What is being tested?
- Dexmedetomidine supplemented morphine analgesia and Morphine analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 12 sitesChina
- Study dates
- 6 Jan 2017to 11 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Affiliated Hospital of Hebei University
Baoding, Hebei, 050031
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
Peking University International Hospital , , China, Contact:
Beijing, Beijing Municipality, 102206
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Chongqing University Fuling Hospital
Chongqing, Chongqing Municipality, 408099
Guizhou Provincial People's Hospital , China, Contact:
Guiyang, Guizhou, 550002
Qingdao Municipal Hospital , , China, Contact:
Qingdao, Shandong, 266011
Shanxi Provincial Cancer Hospital , China, Contact:
Taiyuan, Shanxi, 030013
Tianjin Hospital of ITCWM-Nankai Hospital
Tianjin, Tianjin Municipality, 300100
The Third Central Hospital of Tianjin
Tianjin, Tianjin Municipality, 300170
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710038
About this study
Official title: Impact of Dexmedetomidine Supplemented Analgesia on Long-term Survival in Elderly Patients After Cancer Surgery: a Multicenter Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Elderly, Surgery, Analgesia, Dexmedetomidine, Long-term Outcome
- Being tested
- Dexmedetomidine supplemented morphine analgesia, Morphine analgesia
- Keywords
- Elderly, Surgery, Analgesia, Dexmedetomidine, Long-term outcome
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine supplemented morphine analgesiaDrug
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 analgesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Morphine analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival after surgery
Overall survival is defined as time interval from index surgery to all-cause death after surgery.
Measured: Up to 9 years after surgery
Secondary outcomes (5)
Recurrence-free survival after surgery
Recurrence-free survival is defined as time interval from index surgery to cancer recurrence or metastasis or all-cause death, whichever come first.
Measured: Up to 9 years after surgery
Cancer-specific survival after surgery
Cancer-specific survival is defined as time interval from index surgery to cancer-specific death; patients who died from other causes will be censored at the time of death.
Measured: Up to 9 years after surgery
Event-free survival after surgery
Event-free survival is defined as time interval from index surgery to cancer recurrence or metastasis, new cancer or other major medical events, or all-cause death, whichever come first.
Measured: Up to 9 years after surgery
Cognitive function of survival patients at 1 and 2 years after surgery
Cognitive function is assessed with Telephone Interview for Cognitive Function-Modified (TICS-M).
Measured: At the end of 1 and 2 years after surgery
Quality of life of survival patients at 1 and 2 years after surgery
Quality of life is assessed with World Health Organization Quality of Life-Bref (WHOQOL-BREF).
Measured: At the end of 1 and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start6 Jan 2017
- Primary completion11 Dec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Hebei University, Qingdao Municipal Hospital, The Second Affiliated Hospital of Air Force Military Medical University, Peking University International Hospital, Guizhou Provincial People's Hospital, The Third Xiangya Hospital of Central South University, Shanxi Province Cancer Hospital, Tianjin Nankai Hospital, Fuling Central Hospital of Chongqing City, Tianjin Third Central Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012971
- Sponsor's protocol ID
- 2016-10-LT
- Status last verified
- Jul 2026
- First submitted
- 31 Dec 2016
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dyer CB, Ashton CM, Teasdale TA. Postoperative delirium. A review of 80 primary data-collection studies. Arch Intern Med. 1995 Mar 13;155(5):461-5. doi: 10.1001/archinte.155.5.461.
PubMed 7864702McDaniel M, Brudney C. Postoperative delirium: etiology and management. Curr Opin Crit Care. 2012 Aug;18(4):372-6. doi: 10.1097/MCC.0b013e3283557211.
PubMed 22732435Mu DL, Wang DX, Li LH, Shan GJ, Li J, Yu QJ, Shi CX. High serum cortisol level is associated with increased risk of delirium after coronary artery bypass graft surgery: a prospective cohort study. Crit Care. 2010;14(6):R238. doi: 10.1186/cc9393. Epub 2010 Dec 30.
PubMed 21192800Shi CM, Wang DX, Chen KS, Gu XE. Incidence and risk factors of delirium in critically ill patients after non-cardiac surgery. Chin Med J (Engl). 2010 Apr 20;123(8):993-9.
PubMed 20497703Lat I, McMillian W, Taylor S, Janzen JM, Papadopoulos S, Korth L, Ehtisham A, Nold J, Agarwal S, Azocar R, Burke P. The impact of delirium on clinical outcomes in mechanically ventilated surgical and trauma patients. Crit Care Med. 2009 Jun;37(6):1898-905. doi: 10.1097/CCM.0b013e31819ffe38.
PubMed 19384221Quinlan N, Rudolph JL. Postoperative delirium and functional decline after noncardiac surgery. J Am Geriatr Soc. 2011 Nov;59 Suppl 2:S301-4. doi: 10.1111/j.1532-5415.2011.03679.x.
PubMed 22091577Lescot T, Karvellas CJ, Chaudhury P, Tchervenkov J, Paraskevas S, Barkun J, Metrakos P, Goldberg P, Magder S. Postoperative delirium in the intensive care unit predicts worse outcomes in liver transplant recipients. Can J Gastroenterol. 2013 Apr;27(4):207-12. doi: 10.1155/2013/289185.
PubMed 23616958Abelha FJ, Luis C, Veiga D, Parente D, Fernandes V, Santos P, Botelho M, Santos A, Santos C. Outcome and quality of life in patients with postoperative delirium during an ICU stay following major surgery. Crit Care. 2013 Oct 29;17(5):R257. doi: 10.1186/cc13084.
PubMed 24168808Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of delirium are associated with 1-year mortality in an older intensive care unit population. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1092-7. doi: 10.1164/rccm.200904-0537OC. Epub 2009 Sep 10.
PubMed 19745202Bickel H, Gradinger R, Kochs E, Forstl H. High risk of cognitive and functional decline after postoperative delirium. A three-year prospective study. Dement Geriatr Cogn Disord. 2008;26(1):26-31. doi: 10.1159/000140804. Epub 2008 Jun 24.
PubMed 18577850Van Rompaey B, Schuurmans MJ, Shortridge-Baggett LM, Truijen S, Elseviers M, Bossaert L. Long term outcome after delirium in the intensive care unit. J Clin Nurs. 2009 Dec;18(23):3349-57. doi: 10.1111/j.1365-2702.2009.02933.x. Epub 2009 Sep 4.
PubMed 19735334Ouimet S, Kavanagh BP, Gottfried SB, Skrobik Y. Incidence, risk factors and consequences of ICU delirium. Intensive Care Med. 2007 Jan;33(1):66-73. doi: 10.1007/s00134-006-0399-8. Epub 2006 Nov 11.
PubMed 17102966Stuck A, Clark MJ, Connelly CD. Preventing intensive care unit delirium: a patient-centered approach to reducing sleep disruption. Dimens Crit Care Nurs. 2011 Nov-Dec;30(6):315-20. doi: 10.1097/DCC.0b013e31822fa97c.
PubMed 21983504Siddiqi N, Harrison JK, Clegg A, Teale EA, Young J, Taylor J, Simpkins SA. Interventions for preventing delirium in hospitalised non-ICU patients. Cochrane Database Syst Rev. 2016 Mar 11;3(3):CD005563. doi: 10.1002/14651858.CD005563.pub3.
PubMed 26967259Kosar CM, Tabloski PA, Travison TG, Jones RN, Schmitt EM, Puelle MR, Inloes JB, Saczynski JS, Marcantonio ER, Meagher D, Reid MC, Inouye SK. EFFECT OF PREOPERATIVE PAIN AND DEPRESSIVE SYMPTOMS ON THE DEVELOPMENT OF POSTOPERATIVE DELIRIUM. Lancet Psychiatry. 2014 Nov;1(6):431-436. doi: 10.1016/S2215-0366(14)00006-6.
PubMed 25642413