Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction
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|ClinicalTrials.gov Identifier: NCT01809041|
Recruitment Status : Recruiting
First Posted : March 12, 2013
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intra-abdominal and Intrapelvic Surgery||Drug: Sevoflurane Drug: propofol Drug: remifentanil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||684 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparison of Total Intravenous Anesthesia With Sevoflurane-based Balanced Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients for Major Elective Intra-abdominal Surgery|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
Experimental: Sevoflurane & remifentanil
sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery.
Active Comparator: propofol & remifentanil
propofol (50 - 150 µg/kg/min) and remifentanil (0.1 - 0.5 µg/kg/min)
- Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure) [ Time Frame: At 7 days after the surgery ]Incidence of POCD in patients will be determined by a set of cognitive tests.
- Number of patients with postoperative cognitive dysfunction (POCD) (POCD is a composite outcome measure) [ Time Frame: At 3 months after the surgery ]Incidence of POCD in patients will be determined by a set of cognitive tests.
- Time for bowel function return after surgery [ Time Frame: up to 2 weeks after the surgery ]when bowel movement is returned.
- Degree of increase of stress hormones [ Time Frame: Up to 1 day after the surgery ]blood concentrations of stress hormones.
- Length of hospital stay [ Time Frame: Up to 3 months after the surgery ]duration of staying in the hospital
- colorectal cancer progress [ Time Frame: Up to one year after the surgery ]Migration, invasion and metastasis of the cancer
- degree of systemic inflammation [ Time Frame: Up to 7 days after surgery ]inflammatory cytokines in the blood
- aging biochemical markers [ Time Frame: Up to 7 days after surgery ]such as length of the telomere
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809041
|Contact: Yujuan Li, MD, PhD.||email@example.com|
|Contact: Shulin Peng, MD, PhDfirstname.lastname@example.org|
|Sun Yat-Sen Memorial Hospital||Recruiting|
|Guangzhou, Guangdong, China, 510120|
|Contact: Yujuan Li, MD, Ph.D. 15918734156 Yujuan_04@hotmail.com|
|Principal Investigator: Yujuan Li|