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Does applying different time intervals between administering midazolam and ketamine affect the the delirium effect of ketamine in minor gynecologic surgeries after the patient has awakened from anesthesia.

Effect of time pause between the administration of midazolam and ketamine on post- anesthetic delirium of ketamine in minor gynecologic surgeries

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016010518091N7
Enrollment
100
Registered
2016-02-26
Start date
2016-01-10
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

Delirium after ketamine administration in minor gynecological operations. Postoperative delirium

Interventions

Intervention 1: First group (zero minute): administering intravenous midazolam 0.05 mg/kg and immediately after this administering intravenous ketamine 1.5 mg/kg. Intervention 2: Second group (two and
Treatment - Drugs
Forth group (seven and half minutes): administering intravenous midazolam 0.05 mg/kg and after 7.5 minutes administering intravenous ketamine 1.5 mg/kg
Second group (two and half minutes): administering intravenous midazolam 0.05 mg/kg and after 2.5 minutes administering intravenous ketamine 1.5 mg/kg
Third group (five minutes): administering intravenous midazolam 0.05 mg/kg and after 5 minutes administering intravenous ketamine 1.5 mg/kg
First group (zero minute): administering intravenous midazolam 0.05 mg/kg and immediately after this administering intravenous ketamine 1.5 mg/kg

Sponsors

Hormozgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criterion: women aged between 16-56 years old with minor gynecologic surgeries which last less than 20 minutes; elective surgery; sent to recovery after surgery; class ASA I & II. Exclusion criterion: history of sensitivity to midazolam or ketamine; history of psychiatric and neurological illnesses; history of heart disease and/or kidney failure under treatment; addiction to drugs or psychotropic substances; body mass index of over 30 or under 18.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Rest Score. Timepoint: After being able to obey to commands in recovery room. Method of measurement: screening scale (1 = very calm, 2 = calm, 3 = restless, 4 = very restless, 5 = extremely restless).;Talk Score. Timepoint: After being able to obey to commands in recovery room. Method of measurement: (1 = very quiet, 2 = quiet, 3 = talked a little, 4 = talked a lot, 5 = called or cried out).;Delirium Score. Timepoint: After being able to obey to commands in recovery room. Method of measurement: (1 = definitely not, 2 = no, 3 = perhaps, 4 = yes, 5 = definitely yes).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Vatankhah

Hormozgan University of Medical Sciences

hormozgan91@yahoo.com+98 76 3334 5009

Outcome results

None listed

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