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Effects of Propofol and Ketofol (Ketamine-Propofol mixture) on Emergence Agitation in Children

Comparison of effects of Propofol and Ketofol (Ketamine-Propofol mixture) on Emergence Agitation in Children undergoing Tonsillectomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017082829414N3
Enrollment
87
Registered
2017-10-29
Start date
2017-10-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postanesthesia agitation. Factors influencing health status and contact with health services

Interventions

Intervention 1: Group p, control group, n=44, infusion of propofol 100µg/kg/min. Intervention 2: Group k or ketofol , intervention group, n= 43:infusion of ketamine 25µg/kg/min + propofol 75µg/kg/min.
Treatment - Drugs
Group p, control group, n=44, infusion of propofol 100µg/kg/min
Group k or ketofol , intervention group, n= 43:infusion of ketamine 25µg/kg/min + propofol 75µg/kg/min

Sponsors

Vice chancellor for research, Zanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria are: age between 3-12 years old; ASA class I and II and elective tonsillectomy. Exclusion criteria are: increased intracranial or intraocular pressure; porphyria; hepatic dysfunction; allergy to eggs or soybeans; history of psychiatric disorder; upper respiratory tract infection.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Postanesthesia agitation. Timepoint: On arrival and after 10 and 30 min stay in recovery. Method of measurement: Pediatric Anesthesia Emergence Delirium.

Secondary

MeasureTime frame
Laryngospasm. Timepoint: First 30 min in recovery. Method of measurement: By anesthesiologist.;Bronchospasm. Timepoint: First 30 min in recovery. Method of measurement: By anesthesiologist.;Patients requiring sedative. Timepoint: First 30 min in recovery. Method of measurement: By anesthesiologist.;Bleeding. Timepoint: First 30 min in recovery. Method of measurement: By anesthesiologist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Esmaeli

Zanjan University of Medical Sciences

ALI.ESMAEILI26@YAHOO.COM+98 24 3302 3270

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026