NCT02974712

Brief Summary

This study aims to investigate the effects of different methods of administration on emergence period after laryngeal mask anesthesia in elderly patients undergoing transurethral endoscopic operation

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

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 14, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

November 14, 2016

Last Update Submit

November 25, 2016

Conditions

Mean Arterial PressureHeart Rate

Keywords

Arterial blood gasesMAPHR

Outcome Measures

Primary Outcomes (1)

  • Mean arterial pressure (MAP)

    One hour after surgery

Secondary Outcomes (1)

  • Lengths of stays in the Post anesthesia care unit(PACU)

    One hour after surgery

Study Arms (2)

Fentanyl

EXPERIMENTAL

After routine Induction, fentanyl was administrated.

Drug: Fentanyl

Saline

PLACEBO COMPARATOR

After routine Induction, same volume saline was administrated.

Drug: Saline

Interventions

FentanylDRUG
Fentanyl
SalineDRUG
Saline

Eligibility Criteria

Age65 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ASA level I or II,
  • Aged from 65 to 79,
  • With a duration of anesthesia \<90 min.

You may not qualify if:

  • Chronic obstructive pulmonary diseases (COPD),
  • Severe heart disease,
  • Difficult airway
  • Liver and kidney dysfunction,
  • Cerebrovascular disease,
  • Bleeding volume \>20 ml.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

FentanylSodium Chloride

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 28, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

November 28, 2016

Record last verified: 2016-11