Effect of ketamine and haloperidol with pethidine and haloperidol for prevention of catheter-related bladder discomfort

Comparison of catheter-related bladder discomfort in the two methods of Haloperidol and Ketamine with Haloperidol and Pethidine in male patients after elective lumbar spine Laminectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20171012036730N2

Enrollment

119

Registered

2018-02-25

Start date

2016-09-22

Completion date

Unknown

Last updated

2018-03-26

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

Conditions

Catheter related bladder discomfort. Urinary catheterization as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

Interventions

Intervention 1: Intervention 1: 0.04 mg/kg haloperidol and 0.5 mg/kg ketamine. Intervention 2: Intervention 2: 0.04 mg/kg haloperidol and 0.5 mg/kg pethidine. Intervention 3: Intervention 3: Normal sa

Eligibility

Sex/Gender

Male

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 70 years Male gender American Society of Anesthesiologists (ASA) physical status classification I, II

Exclusion criteria

Exclusion criteria: Inability of extubating the patients after surgery Any history of urological surgery Patients who have any damage or distracting pain other than the site of surgery Patients with any lesion and central nervous system disease History of chronic pain History of opioids or other substances consumption chronically Benign Prostatic Hyperplasia or any urinary system obstruction Urinary tract infection or urinary tract stone Severe heart and liver disease or evidence of long QT segment in electrocardiography History of overactive bladder (need to urinate more than 3 times during sleep or more than 8 times a day) Obesity (body mass index more than 40 kilogram per square meter) Dementia or any disorder which leads to inappropriate orientation and inability to communicate verbally End stage renal disease (urinary volume less than 500cc per 24 hours) Proved mental illness Any apparent bladder dysfunction due to lumbar spinal cord stenosis Sensitivity to phenylephrine, ketamine or pethidine History of monoamine oxidase inhibitor (MAOI) usage in the recent two weeks

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: 0, 1, 6, 24 hours after surgery. Method of measurement: Visual Analogue Scale (VAS).;Sedation. Timepoint: 0, 1, 6, 24 hours after surgery. Method of measurement: Richmond Sedation Score (RSS).;Catheter Related Bladder Discomfort severity. Timepoint: 0, 1, 6, 24 hours after surgery. Method of measurement: based on asking patients based on Likert scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNazafarin Kamalzadeh

Tehran University of Medical Sciences

nkamalzadeh@razi.tums.ac.ir+98 21 6634 8500

Outcome results

None listed

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