S Ketamine Use in Total Abdominal Hysterectomy

NCT02543385 | Withdrawn

• 1 other identifier: 2008/905/D
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigates the effect of low dose S+ketamine compared to placebo on cumulative morphine consumption at 24 hours in women undergoing open abdominal hysterectomy with remifentanil-propofol target controlled infusion. It compares the adverse effect profile in patients receiving S+ketamine as compared to those who did not. Participants are randomly distributed in two groups of 45 patient's each.

Conditions

Total Abdominal Hysterectomy

Keywords

S Ketamine; Morphine; Consumption

Outcome Measures

Primary Outcomes (1)

• S ketamine used in TAH

  1 YEAR

Study Arms (2)

SKET

ACTIVE COMPARATOR

Intravenous S+ketamine 0.25 mg/kg (i.v. bolus) at the beginning and 0.25 mg/kg (i.v. bolus) 20 minutes before extubation along with remifentanil according to Minto model and propofol infusion according to Schnider model through target control infusion pump.

Drug: S Ketamine

PLACEBO

PLACEBO COMPARATOR

Intravenous normal saline (as placebo, with similar volume) at the beginning and 20 minutes before extubation along with remifentanil according to Minto model and propofol according to Schnider model through target control infusion pump.

Drug: S Ketamine

Interventions

S Ketamine DRUG

S+ketamine will be given in group I only in the doses of 0.25mg/kg (iv bolus) before induction along with midazolam and 0. 25 mg/kg (iv bolus) 20 minutes prior to extubation

PLACEBO; SKET

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females above the age of 21 years old scheduled undergoing open abdominal hysterectomy with remifentanil-propofol TCI in KKH for benign condition (fibroids, adenomyosis),
• Be willing and able to give written informed consent for participation in this study
• ASA I/II patient's.

You may not qualify if:

• Patient with contraindications to the use of S+ketamine, as listed in the product label e.g. untreated or insufficiently treated thyroid hyperfunction, unstable angina pectoris or myocardial infarction within the last 6 months, diseases of the CNS, increased intraocular pressure and perforating ocular injuries, surgical procedures in the upper respiratory tract, etc
• Patients with a h/o drug or alcohol abuse
• Regular use of analgesics, or use of opioids within 12 hours of surgery
• Patient on chronic use of benzodiazepine or neurololeptics
• Patient on thyroid replacement hormone
• H/o IHD,HTN,Thyroid disorder.
• BMI\> 30kg/m2.
• H/o Psychiatric disorder.
• Laproscopic surgery converted to open surgery.
• Pregnant or breast feeding female's.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 15, 2024

Record last verified: 2024-10