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Comparison of painless effects between ketamin and combination of ketamin and bupivacaine in patient with renal calculi

Comparison of painless effects between ketamin and combinations of different doses of ketamin and bupivacaine after Percutaneous Nephrolithotripsi (PCNL) in patients with renal calculi.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013092612695N1
Enrollment
50
Registered
2013-10-14
Start date
2012-03-20
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

Nephrolithiasis. Nephrolithiasis NOS

Interventions

Intervention 1: 1th Intervention:2 cc of bupivacaine 0.5%, 6 ml of distilled water. Intervention 2: 2th Intervention: 2 cc of bupivacaine 0.5%, 5 ml of distilled water and 1cc of ketamine 5%. Interven
Treatment - Drugs
Placebo
1th Intervention:2 cc of bupivacaine 0.5%, 6 ml of distilled water
2th Intervention: 2 cc of bupivacaine 0.5%, 5 ml of distilled water and 1cc of ketamine 5%
3th Intervention: 2 cc of bupivacaine 0.5%, 5 ml of distilled water and 1cc of ketamine 5%
4th Intervention: ketamine 5%, 1mg/kg
Control: 2 cc of normal saline

Sponsors

Deputy of Research,Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- 18-75 years. 2- Presence of calculi only in kidney itself. Exclusion criteria: 1- Drug abuser 2- Pregnancy 3- History of renal disease 4- Serum creatinine level more than 2mg/dl 5- History of uncontrolled Hypertension 6- History of psychological disorders and use of psychoactive drug

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: 5-10-15-30 min after extubation, recovery, 1-6-12-24 hours after the patient has been transferred to the ward. Method of measurement: Visual Analogue Scale.;Opioid consumption. Timepoint: Recovery and 24 hour after surgery. Method of measurement: mg.

Secondary

MeasureTime frame
Agitation. Timepoint: 5-10-15-30 min after extubation, recovery, 1-6-12-24 hours after ward admission. Method of measurement: Richmond Agitation Sedation Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Khajavi

Sina Hospital, Tehran University of Medical Sciences

KHAGAVIM@TUMS.AC.IR+98 21 6312 0000

Outcome results

None listed

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