Intraoperative Dexmedetomidine and Long-term Outcomes in Elderly After Major Surgery
Study Details
Study Description
Brief Summary
This is a 3-year follow-up of patients enrolled in a previous randomized controlled trial which showed that intraoperative dexmedetomidine reduced delirium in elderly patients after major non-cardiac surgery. The purpose of this study is to clarify the effects of intraoperative dexmedetomidine on long-term outcomes of these patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Dexmedetomidine is a highly selective α-2-receptor agonist with sedative, analgesic and anxiolytic effects. When used as an supplement during general anaesthesia, it reduces the consumption of the anaesthetics and relieves surgery-related stress response and inflammation. In a recent randomized ontrolled trial of the applicants, 620 elderly patients who underwent major non-cardiac surgery were randomized to receive dexmedetomidine or normal saline during general anesthesia. The results showed that use of dexmedetomidine reduced delirium (5.5% [17/309] with dexmedetomidine vs. 10.2% [32/310] with placebo, P=0.026) and 30-day non-delirium complications (9.4% [60/309] with dexmedetomidine vs. 26.1% [81/310] with placebo, P=0.047) after surgery.
The effects of intraoperative dexmedetomidine on long-term outcomes after surgery remains unclear. In another study of the applicants, use of low-dose dexemeditomidine in ICU patients after surgery increased survival up to 2 years and improve quality of life in 3-year survivors. On the contrary, it was reported in a retrospective study that intraoperative use of dexmedetomidine was associated with shortened overall survival in patients after lung cancer surgery. Therefore, it is urgent to clarify the impact of intraoperative dexemeditomidine on long-term outcomes of patients undergoing major surgery, especially those undergoing cancer surgery.
This study is a 3-year follow-up of patients who were enrolled in a randomzied controlled trial of the applicants in order to clarify the effects of intraoperative dexmedetomidine on long-term outcomes after surgery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group A loading dose of dexmedetomidine (0.6 μg/kg) was administered during a 10-minute period before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery. |
Drug: Dexmedetomidine
A loading dose of dexmedetomidine (0.6 μg/kg) was administered during a 10-minute period before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery.
Other Names:
|
| Placebo Comparator: Control group Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group. |
Drug: Placebo
Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall survival within 3 years after surgery [Up to 3 years after surgery.]
Overall survival within 3 years after surgery
Secondary Outcome Measures
- Recurrence-free survival within 3 years after surgery. [Up to 3 years after surgery.]
Recurrence-free survival within 3 years after surgery.
- Cancer-specific survival within 3 years after surgery. [Up to 3 years after surgery.]
Cancer-specific survival within 3 years after surgery.
- Rate of new-onset disease or hospital readmission within 3 years after surgery. [Up to 3 years after surgery.]
Rate of new-onset disease or hospital readmission within 3 years after surgery.
- Quality of life in 3-year survivors. [At 3 years after surgery.]
Quality of life is assessed with the World Health Organization Quality of Life-Brief Version. It assesses the quality of life at 4 domains, i.e., physical, psychological, social relationships, and environment. The score of each domain ranges from 0 to 100, with higher score indicating better quality of life.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Elderly patients (age ≥60 years);
-
Scheduled to undergo elective major non-cardiac surgery with expected duration ≥2 hours under general anaesthesia.
Exclusion Criteria:
-
Do not provide written informed consent;
-
Previous history of schizophrenia, epilepsy or Parkinson's disease;
-
Visual, hearing, language or other barriers which impede communication and preoperative delirium assessment;
-
History of traumatic brain injury;
-
Severe bradycardia (heart rate <40 beats per minutes), sick sinus syndrome, or atrioventricular block of degree 2 or above without pacemaker;
-
Severe hepatic dysfunction (Child-Pugh grade C);
-
Renal failure (requirement of renal replacement therapy);
-
Neurosurgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University First Hospital | Beijing | Beijing | China | 100034 |
Sponsors and Collaborators
- Peking University First Hospital
Investigators
- Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Abdel-Meguid ME. Dexmedetomidine as anesthetic adjunct for fast tracking and pain control in off-pump coronary artery bypass. Saudi J Anaesth. 2013 Jan;7(1):6-8. doi: 10.4103/1658-354X.109557.
- Cata JP, Singh V, Lee BM, Villarreal J, Mehran JR, Yu J, Gottumukkala V, Lavon H, Ben-Eliyahu S. Intraoperative use of dexmedetomidine is associated with decreased overall survival after lung cancer surgery. J Anaesthesiol Clin Pharmacol. 2017 Jul-Sep;33(3):317-323. doi: 10.4103/joacp.JOACP_299_16.
- Gerresheim G, Schwemmer U. [Dexmedetomidine]. Anaesthesist. 2013 Aug;62(8):661-74. doi: 10.1007/s00101-013-2206-6. Review. German.
- Jalonen J, Hynynen M, Kuitunen A, Heikkilä H, Perttilä J, Salmenperä M, Valtonen M, Aantaa R, Kallio A. Dexmedetomidine as an anesthetic adjunct in coronary artery bypass grafting. Anesthesiology. 1997 Feb;86(2):331-45.
- Li Y, Wang B, Zhang LL, He SF, Hu XW, Wong GT, Zhang Y. Dexmedetomidine Combined with General Anesthesia Provides Similar Intraoperative Stress Response Reduction When Compared with a Combined General and Epidural Anesthetic Technique. Anesth Analg. 2016 Apr;122(4):1202-10. doi: 10.1213/ANE.0000000000001165.
- Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
- Wang BJ, Li CJ, Hu J, Li HJ, Guo C, Wang ZH, Zhang QC, Mu DL, Wang DX. Impact of dexmedetomidine infusion during general anaesthesia on incidence of postoperative delirium in elderly patients after major non-cardiac surgery: study protocol of a randomised, double-blinded and placebo-controlled trial. BMJ Open. 2018 Apr 21;8(4):e019549. doi: 10.1136/bmjopen-2017-019549.
- Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.
- 2019-0927