NCT04111926

Intraoperative Dexmedetomidine and Long-term Outcomes in Elderly After Major Surgery

Impact of Intraoperative Dexmedetomidine on Long-term Outcomes in Elderly Patients After Major Non-cardiac Surgery: 3-year Follow-up of a Randomised Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 619 (actual)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Overall Survival

Interventions

Type	Name	Description
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.
DRUG	Placebo	Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group.

Timeline

• Start date: 2019-10-07
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2019-10-01
• Last updated: 2022-04-20

Locations

1 site across 1 country: China