Dexmedetomidine Supplemented Analgesia and Incidence of Postoperative Delirium

Summary

Delirium is a frequently occurred cerebral complication in elderly patients after surgery, and its occurrence is associated with worse outcomes. Sleep disturbances is considered to be one of the most important risk factors of postoperative delirium. Previous studies showed that, for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine infusion improved the quality of sleep and decreased the incidence of delirium. The investigators hypothesize that, for elderly patients after cancer surgery, dexmedetomidine supplemented analgesia can also decrease the incidence of delirium, possibly by improving sleep quality. The purpose of this multicenter, randomized controlled trial is to investigate the impact of dexmedetomidine supplemented analgesia on the incidence of delirium in elderly patients after cancer surgery.

Conditions

• Elderly
• Surgery
• Analgesia
• Dexmedetomidine
• Complication, Postoperative
• Delirium

Interventions

DRUG

Dexmedetomidine supplemented morphine analgesia

Patients in this group will 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 each time and a lockout time from 6 to 8 minutes according to patients' condition.

DRUG

Morphine analgesia

Patients in this group will 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 each time and a lockout time from 6 to 8 minutes according to patients' condition.

Sponsors & Collaborators

• Affiliated Hospital of Hebei University

  collaborator OTHER

• Qingdao Municipal Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Air Force Medical University

  collaborator UNKNOWN

• Peking University International Hospital

  collaborator OTHER

• Guizhou Provincial People's Hospital

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• Shanxi Provincial Cancer Hospital

  collaborator UNKNOWN

• Tianjin Hospital of ITCWM-Nankai Hospital

  collaborator UNKNOWN

• Chongqing University Fuling Hospital

  collaborator UNKNOWN

• The Third Central Hospital of Tianjin

  collaborator UNKNOWN

• Xiyuan Hospital of China Academy of Chinese Medical Sciences

  collaborator OTHER

• Peking University First Hospital

  lead OTHER

Principal Investigators

• Dong-Xin Wang, MD,PhD · Peking University First Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-06

Primary Completion

2022-05-12

Completion

2022-06-11

Countries

• China

Study Locations