NCT05139212

Brief Summary

Inhalational induction with sevoflurane, nitrous oxide, and oxygen is accepted as a safe technique to avoid any movement during intravenous cannulation in children. In addition, intranasal dexmedetomidine could be used for premedication to reduce preoperative anxiety in preschool children. Early attempts to place, an intravenous line may result in movement and respiratory complications like coughing or laryngospasm. On the other hand delay in cannulation may prevent effective management of bradycardia and hypotension. There are a number of studies examining the optimum time for cannulation after sevoflurane induction. However, it is not known whether the addition of dexmedetomidine premedication affects the time for intravenous cannulation following induction with sevoflurane and nitrous oxide.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

December 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2022

Completed
Last Updated

February 7, 2022

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

November 17, 2021

Last Update Submit

February 4, 2022

Conditions

CannulationSevoflurane InductionDexmedetomidine

Keywords

Induction of anesthesiaSevofluraneNitrous oxideDexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • Determination of optimum time for intravenous cannulation after induction with sevoflurane and nitrous oxide in children premedicated with dexmedetomidine

    At the time of intravenous canulation attempt, an independent observer who will be blinded about predetermined canülation time, rated the movement according to a scale (0= no movement 1= slight extremity tensing, 2= extremity withdrawal, 3=generalized movement. Intravenous cannulation without any laryngospasm or movement will be considered successful.

    The outcome will be assessed at the time of intravenous cannulation attempt.

Secondary Outcomes (2)

  • To assess level of preoperative sedation

    Assesment of children will be started from acceptance of patient to preoperative holding area to the time of anesthesia preparation.

  • To assess level of preoperative anxiety

    Assesment of children will be started from acceptance of patient to preoperative holding area to the time of anesthesia preparation.

Interventions

Optimum time for intravenous cannulation in children premedicated with dexmedetomidinePROCEDURE

The optimum time for intravenous cannulation after the induction of anesthesia with sevoflurane, oxygen, and nitrous oxide in children with intranasal dexmedetomidine premedication will be searched in children undergoing elective surgery.

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 2-6 years, American Society of Anesthesiologists physical status 1 scheduled for elective procedures undergoing inhalational induction after dexmedetomidine premedication without intravenous access will be enrolled in the study.

You may qualify if:

  • Children with ASA physical status I and scheduled for an elective procedure under general anesthesia without prior intravenous cannulation will be selected

You may not qualify if:

  • Children posted for any emergency procedure
  • ASA class II and above,
  • Children with abnormal airway anatomy.
  • Children with active respiratory infection in the last 3 weeks.
  • Children who are being treated with sedative or anticonvulsive agents.
  • Children with heart, lung, neurologic, or central nervous system disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Taining and Research Hospital

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Rafet Yarimoglu, MD

    Karaman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 1, 2021

Study Start

December 2, 2021

Primary Completion

February 4, 2022

Study Completion

February 4, 2022

Last Updated

February 7, 2022

Record last verified: 2021-11

Locations

TU(1)