NCT02110745

Brief Summary

The objective of this study was to determine (a) whether patients anesthetized with intravenous propofol have less pain compared with sevofluorane for paediatric inguinal hernia and undescended testis operations and (b) whether intravenous propofol anesthesia has better quality of recovery compared with sevofluorane anesthesia in the immediate postoperative period after paediatric inguinal hernia and undescended testis operations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_4

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

March 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

March 26, 2014

Last Update Submit

March 12, 2015

Conditions

Hernia, InguinalCryptorchidism

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Postoperative 24 hours

Secondary Outcomes (1)

  • Postoperative agitation

    postoperative 24 hours

Other Outcomes (1)

  • Postoperative complications

    Postoperative 24 hours

Study Arms (2)

Sevofluorane

EXPERIMENTAL

Sevofluorane 8% in induction

Drug: Sevofluorane

Propofol

EXPERIMENTAL

Propofol 2.5 mg/kg intravenous in induction

Drug: Propofol

Interventions

SevofluoraneDRUG

Comparison of different induction drugs and techniques

Also known as: Sevorane
Sevofluorane
PropofolDRUG

Comparison of different induction drugs and techniques

Also known as: pofol
Propofol

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • American Society of Anesthesiologists I-II
  • years old patients
  • Patients for elective inguinal hernia and undescended testis operations.

You may not qualify if:

  • Children with developmental problems
  • Cerebral palsy
  • Down syndrome
  • Inborn errors of metabolism
  • A history of epileptic fits
  • Body weight less than 10 kg or greater than 30 kg (children below age of 6 years with body weight more than 30 kg are definitely obese with a risk of airway obstruction along with the abnormal volume of distribution of drugs if given according to their actual body weight)
  • Patients with known allergy to any of the medications used
  • Procedures lasted less than 30 min or longer than 2 h.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Kemal University Medicine Faculty Anesthesiology Department

Hatay, 31000, Turkey (Türkiye)

Location

Related Publications (2)

  • Tan T, Bhinder R, Carey M, Briggs L. Day-surgery patients anesthetized with propofol have less postoperative pain than those anesthetized with sevoflurane. Anesth Analg. 2010 Jul;111(1):83-5. doi: 10.1213/ANE.0b013e3181c0ee9e. Epub 2009 Nov 12.

    PMID: 19910624RESULT

  • Li M, Mei W, Wang P, Yu Y, Qian W, Zhang ZG, Tian YK. Propofol reduces early post-operative pain after gynecological laparoscopy. Acta Anaesthesiol Scand. 2012 Mar;56(3):368-75. doi: 10.1111/j.1399-6576.2011.02603.x. Epub 2011 Dec 23.

    PMID: 22192060RESULT

Related Links

MeSH Terms

Conditions

Hernia, InguinalCryptorchidism

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsTesticular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrogenital AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Selim Turhanoglu, Prof

    Mustafa Kemal University medicine faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist.Prof

Study Record Dates

First Submitted

March 26, 2014

First Posted

April 10, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations

TU(1)