Intraoperative Dexmedetomidine & Long-term Outcomes in Elderly After Major

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Overall Survival

Clinical Trial Details

NCT number	NCT04111926
Study type	Interventional
Source	Peking University First Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	October 7, 2019
Completion date	April 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04025840` - Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery	Phase 4
Recruiting	`NCT04101760` - Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer	Phase 3
Withdrawn	`NCT03342300` - Pegylated Liposomal Doxorubicin Versus Pirarubicin Plus Ifosfamide, Dacarbazine in Locally Advanced, Unresectable or Metastatic Soft-tissue Sarcoma	Phase 2/Phase 3
Recruiting	`NCT03910140` - TILA-TACE in Treatment of Hepatocellular Carcinoma	N/A
Completed	`NCT03923400` - Jejunoileal vs Gastric GIST in the Era of Imatinib.
Withdrawn	`NCT02201381` - Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer	Phase 3
Recruiting	`NCT05392257` - Efficacy and Safety of Rituximab Plus Zanubrutinib and Lenalidomide for Relapsed and Refractory Diffuse Large B Cell Lymphoma, a Multicenter, Open and Prospective Clinical Trial	Phase 2
Recruiting	`NCT05310370` - HRD and Resistance to PAPPi in EOC Patients
Recruiting	`NCT05310357` - Chromosomal Instability in Ovarian Cancer
Recruiting	`NCT05310305` - PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer
Active, not recruiting	`NCT04245644` - Efficacy of Chemopreventive Agents on Disease-free and Overall Survival in Patients With Pancreatic Ductal Adenocarcinoma: The CAOS Study
Recruiting	`NCT04245410` - Surgical Treatment of Pancreatic Metastases From Renal Cell Carcinoma
Completed	`NCT02980185` - Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer	N/A
Recruiting	`NCT03967457` - Comprehensive Study on the Quality of Life in Cervical Cancer Patients
Recruiting	`NCT04050787` - Spleen-Preserving No. 10 Lymph Node Dissection in Gastric Cancer	N/A
Recruiting	`NCT03892577` - Real-world Study for Patients With Advanced Hepatobiliary Tumors
Completed	`NCT03726021` - Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer	Phase 2
Not yet recruiting	`NCT02942238` - Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)	N/A
Not yet recruiting	`NCT01236989` - Prognostic Impact of Anatomical Resection Vs. Non-anatomical Resection for HCC	N/A
Recruiting	`NCT05218629` - Anlotinib Plus PD-1 Inhibitor as 2nd-line Threapy in Patients With Metastatic Pancreatic Cancer	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms