NCT03770130

Dexmedetomidine and Liver Transplantation

Evaluation of the Impact of Dexmedetomidine on Allograft Function Recovery and Survival Following Liver Transplantation: A Randomised Control Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

1.1. Background 1.1.1. Perioperative ischaemia/reperfusion (I/R) injury during liver transplantation is strongly associated with early allograft dysfunction, graft loss, and mortality. 1.1.2. Hepatic I/R injury also causes remote damage to other organs including the renal and pulmonary systems. 1.1.3. Dexmedetomidine, a selective α2-adrenoceptor agonist which is widely used as an adjuvant to general anaesthesia, has been widely shown in preclinical studies to provide organoprotection by ameliorating the effects of I/R injury in a range of tissues (including the liver). However, prospective clinical evidence of any potential benefits in improving outcomes in liver transplantation is lacking. 1.2. Objectives 1.2.1. To investigate the hypothesis that perioperative treatment with dexmedetomidine reduces the incidence of early allograft dysfunction and primary graft non-function in deceased donor liver transplantation. 1.2.2. The impact of dexmedetomidine on postoperative renal and pulmonary function will also be examined. 1.3. Study Design This is a prospective, single-centre, randomised, parallel-group study. 1.4. Setting Departments of Anesthesiology, Renji Hosptial, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China. 1.5. Patients 200 patients (18-65 years) scheduled to undergo liver transplantation under general anaesthesia. 1.6 Intervention 1.6.1. For the patients in the treatment group, a loading dose of dexmedetomidine will be given after induction of anaesthesia (1μg/kg over 10 min) followed by a continuous infusion (0.5μg/kg /h) until the end of surgery. 1.6.2. For patients in the placebo group, an equal volume loading dose of 0.9% saline will be given after the induction of anaesthesia followed by an equal volume continuous infusion until the end of surgery. 1.6.3. All other supplements, e.g. opioids, sedatives and muscle relaxant, will be identical in the both arms and administered according to routine clinical practice.

Conditions

• Dexmedetomidine, Liver Transplantation, Allograft Function, Survival

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Dexmedetomidine, a selective α2-adrenoceptor agonist which is widely used as an adjuvant to general anaesthesia
DRUG	Saline	Saline, a kind of crystalloid widely used in clinical treatment

Timeline

• Start date: 2019-01-14
• Primary completion: 2022-10-31
• Completion: 2022-12-31
• First posted: 2018-12-10
• Last updated: 2023-08-21

Locations

1 site across 1 country: China