A clinical trial to study of two drugs, ketamine and s-ketamine in surgeries for lower abdomen or other lower extremities.

A double blind randomized comparative controlled study of efficacy and duration of analgesia for Intrathecal Ketamine & S-Ketamine in Surgeries for Lower Abdomen or other Lower Extremities - KPS Clinical Services Pvt. Ltd.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/006091

Enrollment

200

Registered

2011-01-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: s-ketamine: 75mg in 5% dextrose, with and without 1:200,000 epinephrine I.V. Control Intervention1: Ketamine: 75mg in 5% dextrose, with and without 1:200,000 epinephrine I.V.

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients(Male or Female) undergoing Surgeries for Lower Abdomen or other Lower Extremities 2.ASA GRADE I/II/III 3.Age between 30-60 years 4.Body mass index < 35 kg/m2

Exclusion criteria

Exclusion criteria: 1.Patients with respiratory, cardiac dieses, liver, kidney, neurological disorder 2.Diabetes , hypertension 3.Psychiatric disorder 4.Infection on back 5.Coagulation disorder ? Raised intracranial tension

Design outcomes

Primary

Measure	Time frame
1.Postoperative abilities over time 2.Discharge time according to fixed criteria 3.Consumption of analgesics and anti emeticsTimepoint: 1.Postoperative abilities over time 2.Discharge time according to fixed criteria 3.Consumption of analgesics and anti emetics	—

Secondary

Measure	Time frame
1.Degree of nursing requirements 2.General tolerability of the regimes 3.Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively 4.A modified Bromage score should be used to measure motor block. Timepoint: After the injection, followed by every 2 min for the first 15 min and every 5 min thereafter throughout the surgery and until the complete reversal of analgesia and motor blockade occurs.	—

Measure

Time frame

1.Degree of nursing requirements 2.General tolerability of the regimes 3.Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively 4.A modified Bromage score should be used to measure motor block. Timepoint: After the injection, followed by every 2 min for the first 15 min and every 5 min thereafter throughout the surgery and until the complete reversal of analgesia and motor blockade occurs.

—

Countries

India

Contacts

Public ContactMukesh Kumar

abinash@kpsclin.com9654200570

Outcome results