Impact of Anesthesia Maintenance Methods on Incidence of Postoperative Delirium

NCT02662257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1228

Last updated 2022-03-04

No results posted yet for this study

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.

Conditions

  • Delirium
  • Postoperative Complications
  • Postoperative Cognitive Dysfunction

Interventions

DRUG

Sevoflurane

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.

DRUG

Propofol

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.

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    collaborator OTHER
  • The People's Hospital of Ningxia

    collaborator OTHER
  • Beijing Shijitan Hospital, Capital Medical University

    collaborator OTHER
  • Guizhou Provincial People's Hospital

    collaborator OTHER
  • Affiliated Hospital of Qinghai University

    collaborator OTHER
  • The Third Xiangya Hospital of Central South University

    collaborator OTHER
  • Cancer Hospital of Guangxi Medical University

    collaborator OTHER
  • Shanxi Provincial People's Hospital

    collaborator OTHER_GOV
  • Zhongda Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER
  • Tang-Du Hospital

    collaborator OTHER
  • Tianjin Nankai Hospital

    collaborator OTHER
  • Shenzhen Second People's Hospital

    collaborator OTHER
  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD, PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2017-09-29
Completion
2017-11-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02662257 on ClinicalTrials.gov