NCT06123637

Brief Summary

The primary purpose of this study is to compare the analgesia nociception index-guided anesthesia and standard anesthesia on remifentanil requirement in desflurane anesthesia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable gastric-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

November 1, 2023

Last Update Submit

November 7, 2023

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Remifentanil requirement

    Assessing the total dose of remifentanil administered from skin incision until skin suture

    at time of the end of skin suture (up to 4 hours)

Study Arms (2)

Analgesia nociception index group

EXPERIMENTAL
Behavioral: Analgesia nociception index-guided anesthesia

Standard group

PLACEBO COMPARATOR
Behavioral: Standard anesthesia

Interventions

Analgesia nociception index-guided anesthesiaBEHAVIORAL

Maintaining the blood pressure based on analgesia nociception index of \>50 value

Analgesia nociception index group
Standard anesthesiaBEHAVIORAL

Maintaining the blood pressure based on anesthesiologist's decision

Standard group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of gastric cancer

You may not qualify if:

  • Conversion to open laparotomy
  • Prior opioid abuse
  • Prior infection
  • Cardiac arrythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 9, 2023

Study Start

January 2, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

November 9, 2023

Record last verified: 2023-11