The Effects of Two Induction Means on Emergence After Gen... | NCT02974712

Studies
The Effects of Two Induction Means on Emergence After General Anesthesia

NCT02974712

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Nov 28, 2016Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Mean Arterial Pressure
Heart Rate

Interventions

Fentanyl
Saline

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Mar 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Nov 14, 2016

First Submission Date that Met QC Criteria

Nov 25, 2016

First Posted Date

Nov 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2016

Last Update Posted Date

Nov 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fentanyl	Experimental	After routine Induction, fentanyl was administrated.	Drug: Fentanyl
Saline	Placebo Comparator	After routine Induction, same volume saline was administrated.	Drug: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fentanyl	Drug		Fentanyl
Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean arterial pressure (MAP)		One hour after surgery

Secondary Outcomes

Measure	Description	Time Frame
Lengths of stays in the Post anesthesia care unit(PACU)		One hour after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

79 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D002712	Chlorides

Browse Leaves

Not provided

Browse Branches

Not provided