NCT02583217

Brief Summary

Laryngeal mask airway is a common tool for airway management during anesthesia in many surgeries. Insertion of laryngeal mask needs deep anesthesia, suppression of airway, stabile hemodynamic response. Many drug regimens has been used for this purpose. This study aimed to compare the insertion conditions of laryngeal mask by using ketamine+propofol versus remifentanil + propofol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 8, 2017

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

September 18, 2015

Last Update Submit

May 5, 2017

Conditions

Surgery

Keywords

Laryngeal maskKetamineRemifentanyl

Outcome Measures

Primary Outcomes (1)

  • High laryngeal mask insertion scores

    3 minutes

Secondary Outcomes (2)

  • Hypotension

    10 minutes

  • Hypertension

    10 minutes

Study Arms (2)

Ketamine

Ketamine+propofol

Drug: KetamineDrug: propofolDevice: laryngeal mask

Remifentanyl

Remifentanyl+propofol

Drug: remifentanylDrug: propofolDevice: laryngeal mask

Interventions

KetamineDRUG

To compare ketamine+propofol versus remifentanyl+propofol to maintain good laryngeal mask insertion conditions

Also known as: Remifentanyl
Ketamine
remifentanylDRUG
Remifentanyl
propofolDRUG
KetamineRemifentanyl
laryngeal maskDEVICE
KetamineRemifentanyl

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Surgery performed with laryngeal mask as airway tool in gynecologic clinic

You may qualify if:

  • Surgery requires laryngeal mask

You may not qualify if:

  • Patient refusal, abdominal surgery required muscle relaxant, any allergy to ketamine or remifentanyl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cigdem Yildirim Guclu

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

KetamineRemifentanilPropofolLaryngeal Masks

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticIntubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • CIGDEM YILDIRIM GUCLU, MD

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 18, 2015

First Posted

October 22, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 8, 2017

Record last verified: 2016-01

Locations

TU(1)