Dexmedetomidine Supplemented Analgesia and Incidence of Postoperative Delirium

January 6, 2026 updated by: Dong-Xin Wang, Peking University First Hospital

Impact of Dexmedetomidine Supplemented Analgesia on Incidence of Delirium in Elderly Patients After Cancer Surgery: a Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Delirium is a state of acutely occurred and transient cerebral dysfunction. It is a common complication in elderly patients after surgery. A systematic review showed that an average of 36.8% (range 0 to 73.5%) of surgical patients developed postoperative delirium, and its occurrence increased with age. According to our previous studies, postoperative delirium developed in 51.0% of patients after cardiac surgery and in 44.5% of patients after non-cardiac surgery. The occurrence of delirium is associated with worse short-term outcomes, including increased postoperative complications, prolonged hospital stay, and increased in-hospital mortality; it is also associated with worse longterm outcomes, including declined cognitive function, decreased quality of life, and increased post-hospital mortality. Delirium is the result of multiple factors. Studies showed that postoperative pain is an important risk factor of delirium, whereas good postoperative analgesia reduces the incidence of delirium. For postoperative patients, sleep disturbances occurs frequently and increases the risk of delirium, whereas improving sleep quality reduces the incidence of delirium. Furthermore, the studies found that surgery related inflammatory response also plays an important role in the development of delirium.

Dexmedetomidine is a highly selective alpha-2 (α2) adrenoreceptor agonist that provides anxiolysis, sedation, hypnosis and analgesia. It exerts the sedative and hypnotic effects by activating the endogenous sleep pathways, and produces a condition similar to phase 2 non-rapid eye movement sleep. For patients undergoing mechanical ventilation in the ICU, dexmedetomidine sedation helps to maintain a normal circadian rhythm of sleep and improves sleep architecture. Dexmedetomidine also provides analgesic effect by activating α2 adrenergic receptors in the dorsal horn of spinal cord. When used as a supplemental drug it decreases intraoperative and postoperative requirement of opioids. Moreover, animal studies showed that dexmedetomidine significantly inhibits the degree of inflammatory response induced by endotoxin or during spinal cord injury. In clinical studies, dexmedetomidine attenuates the degree of inflammatory response following Coronary Artery Bypass Grafting surgery.

These effects of dexmedetomidine make it suitable for prevention of postoperative delirium in high-risk patients. Studies have shown that, for ICU patients requiring mechanical ventilation, sedation with dexmedetomidine reduces the incidence of delirium when compared with other sedatives; for postoperative patients, dexmedetomidine administered in combined with opioids improves analgesia and reduces opioid requirements. A recent study showed that, for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine infusion (at a rate of 0.1 ug/kg/h, for an average of 15 hours) improves analgesia for up to 24 hours, ameliorates subjective sleep quality for up to 3 days, and reduces the incidence of delirium during the first 7 postoperative days. The investigators hypothesized that the use of dexmedetomidine as a supplement to patient-controlled intravenous analgesia may also reduce the incidence of postoperative delirium.

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, China, 102206
        • Peking University International Hospital
      • Beijing, Beijing Municipality, China, 100091
        • Xiyuan Hospital of China Academy of Chinese Medical Sciences
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 408099
        • Chongqing University Fuling Hospital
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Guizhou Provincial People's Hospital
    • Hebei
      • Baoding, Hebei, China, 050031
        • Affiliated Hospital of Hebei University
    • Hunan
      • Changsha, Hunan, China, 410013
        • The Third Xiangya Hospital of Central South University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • The Second Affiliated Hospital of Air Force Medical University
    • Shandong
      • Qingdao, Shandong, China, 266011
        • Qingdao Municipal Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincial Cancer Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300100
        • Tianjin Hospital of ITCWM-Nankai Hospital
      • Tianjin, Tianjin Municipality, China, 300170
        • The Third Central Hospital of Tianjin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine group
Dexmedetomidine supplemented morphine analgesia will be 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.
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.
Placebo Comparator: Control group
Morphine analgesia will be 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of delirium within 5 days after surgery
Time Frame: During the first 5 days after surgery
Incidence of delirium within 5 days after surgery
During the first 5 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in hospital after surgery
Time Frame: Up to 30 days after surgery
Length of stay in hospital after surgery
Up to 30 days after surgery
Daily prevalence of delirium during the first 5 postoperative days
Time Frame: During the first 5 postoperative days
Daily prevalence of delirium during the first 5 postoperative days
During the first 5 postoperative days
Incidence of non-delirium complications after surgery
Time Frame: Up to 30 days after surgery
Incidence of non-delirium complications after surgery
Up to 30 days after surgery
30-day all-cause mortality after surgery
Time Frame: At the time of 30 days after surgery
30-day all-cause mortality after surgery
At the time of 30 days after surgery
Quality of life in survival patients on the 30th day after surgery
Time Frame: On the 30th day after surgery
Assessed with World Health Organization Quality of Life-Bref (WHOQOL-BREF)
On the 30th day after surgery
Cognitive function in survival patients on the 30th day after surgery
Time Frame: On the 30th day after surgery
Assessed with Telephone Interview for Cognitive Status-Modified (TICS-M)
On the 30th day after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Richmond Agitation-Sedation Scale (RASS) score during the first 5 days after surgery
Time Frame: During the first 5 days after surgery
Richmond Agitation-Sedation Scale (RASS) score during the first 5 days after surgery
During the first 5 days after surgery
Cumulative morphine consumption during the first 3 days after surgery
Time Frame: During the first 3 days after surgery
Cumulative morphine consumption during the first 3 days after surgery
During the first 3 days after surgery
Numeric Rating Scale (NRS) pain score during the first 5 days after surgery
Time Frame: During the first 5 days after surgery
Numeric Rating Scale (NRS) pain score during the first 5 days after surgery
During the first 5 days after surgery
Numeric Rating Scale (NRS) sleep quality score during the first 5 days after surgery
Time Frame: During the first 5 days after surgery
Numeric Rating Scale (NRS) sleep quality score during the first 5 days after surgery
During the first 5 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Peking University International Hospital
Affiliated Hospital of Hebei University
Qingdao Municipal Hospital
The Second Affiliated Hospital of Air Force Medical University
Guizhou Provincial People's Hospital
The Third Xiangya Hospital of Central South University
Shanxi Provincial Cancer Hospital
Tianjin Hospital of ITCWM-Nankai Hospital
Xiyuan Hospital of China Academy of Chinese Medical Sciences
The Third Central Hospital of Tianjin
Chongqing University Fuling Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, MD,PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2017

Primary Completion (Actual)

May 12, 2022

Study Completion (Actual)

June 11, 2022

Study Registration Dates

First Submitted

December 31, 2016

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimated)

January 6, 2017

Study Record Updates

Last Update Posted (Estimated)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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