Dexmedetomidine Supplemented Analgesia and Incidence of Postoperative Delirium
NCT ID: NCT03012984
Last Updated: 2026-01-08
Study Results
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Basic Information
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COMPLETED
NA
1500 participants
INTERVENTIONAL
2017-01-06
2022-06-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
65 Years
90 Years
ALL
No
Sponsors
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Affiliated Hospital of Hebei University
OTHER
Qingdao Municipal Hospital
OTHER
The Second Affiliated Hospital of Air Force Medical University
UNKNOWN
Peking University International Hospital
OTHER
Guizhou Provincial People's Hospital
OTHER
The Third Xiangya Hospital of Central South University
OTHER
Shanxi Provincial Cancer Hospital
UNKNOWN
Tianjin Hospital of ITCWM-Nankai Hospital
UNKNOWN
Chongqing University Fuling Hospital
UNKNOWN
The Third Central Hospital of Tianjin
UNKNOWN
Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology
Principal Investigators
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Dong-Xin Wang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
Chongqing University Fuling Hospital
Chongqing, Chongqing Municipality, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Tianjin Hospital of ITCWM-Nankai Hospital
Tianjin, Tianjin Municipality, China
The Third Central Hospital of Tianjin
Tianjin, Tianjin Municipality, China
Countries
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References
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Other Identifiers
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2016-10
Identifier Type: -
Identifier Source: org_study_id
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