CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,228 enrolled
Drug / intervention
Sevoflurane +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT02662257
NCT02662257N/ACompleted
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Impact of Inhalational Versus Intravenous Anesthesia Maintenance Methods on Incidence of Postoperative Delirium in Elderly Patients After Cancer Surgery: An Open-label, Randomized Controlled Trial

Peking University First Hospital·interventional·Posted Jan 25, 2016·Updated Mar 4, 2022

In Brief

A clinical study evaluating Sevoflurane and Propofol for Delirium and 2 related conditions. Completed, enrolled 1,228 participants across 17 sites.

Detailed Summary

Surgery is one of the major treatment methods for patients with malignant tumor. And, alone with ageing process, more and more elderly patients undergo surgery for malignant tumor. Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous anesthetics, may influence the outcome of elderly patients undergoing cancer surgery. Delirium is a commonly occurred early postoperative cognitive complication in the elderly, and its occurrence is associated with the worsening outcomes. Choice anesthetics may influence the occurrence of postoperative delirium. However, evidence in this aspect is conflicting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelirium, Postoperative Complications, Postoperative Cognitive Dysfunction
CountriesChina
CollaboratorsHebei Medical University Fourth Hospital, The People's Hospital of Ningxia, Beijing Shijitan Hospital, Capital Medical University, Guizhou Provincial People's Hospital, Affiliated Hospital of Qinghai University, The Third Xiangya Hospital of Central South University, Cancer Hospital of Guangxi Medical University, Shanxi Provincial People's Hospital, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Tang-Du Hospital, Tianjin Nankai Hospital, Shenzhen Second People's Hospital

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 25, 2016
Enrollment StartApr 1, 2015
Primary CompletionSep 29, 2017
Study CompletionNov 26, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.4 years ago

Interventions

Sevofluranedrug

Sevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection/continuous infusion), or fentanyl (administered by intermittent injection). Towards the end of surgery, sevoflurane inhalational concentration will be decreased and fentanyl/sufentanil will be administered when necessary. Sevoflurane inhalation will be stopped at the end of surgery.

Propofoldrug

Propofol will be administered by intravenous infusion for anesthesia maintenance. The infusion rate of propofol will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be supplemented with remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection/continuous infusion), or fentanyl (administered by intermittent injection). Towards the end of surgery, propofol infusion rate will be decreased and fentanyl/sufentanil will be administered when necessary. Propofol infusion will be stopped at the end of surgery.