LoopKeta: Ketamine and Closed-Loop Anesthesia System

• Sponsor: Hopital Foch (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02011347
• Collaborator: (none)
• Enrollment: 67
• Locations: 2
• Arms: 2
• Duration (Months): 27.2
• Patients Per Site: 33.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The objective is to evaluate the sparing effect of ketamine on the dose of propofol.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Ketamine; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Influence of Ketamine on a Closed-Loop Anesthesia System
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Oct 7, 2015
• Actual Study Completion Date: Oct 7, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketamine Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Ketamine (bolus dose of Ketamine (0.15 mg.kg-1) followed by an infusion of Ketamine (0.15 mg.kg-1 h-1) until the end of anesthesia)	Drug: Ketamine
Experimental: Placebo patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo (NaCl 9/00 (same volume as in the Ketamine group)	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. administered dose of propofol during maintenance of anesthesia [day 1]

Secondary Outcome Measures

1. bispectral index measurement [1 day]

   bispectral index modification due to ketamine infusion before induction of anesthesia

2. administered dose of propofol during induction of anesthesia [day 1]

3. administered doses of remifentanil during induction and maintenance of anesthesia [day 1]

4. delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia [day 1]

5. hemodynamic abnormalities requiring treatment [day 1]

6. % of time with a bispectral index between 40 and 60 [day 1]

7. postoperative morphine requirement [day 1]

8. incidence of postoperative nausea and vomiting [day 1]

9. White and Song score [day 1]

10. % of patients with an explicit memorisation of the intraoperative period [second postoperative day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with an American Society of Anesthesiology score 1, 2 or 3

• scheduled for a surgical procedure lasting more than 2 hours under general anesthesia

Exclusion Criteria:

• pregnancy

• chronic pain

• simultaneous general and loco-regional anesthesia

• contra-indication to to nonsteroidal anti-inflammatory drug

• contra-indication to Ketamine

• contra-indication to propofol, to remifentanil, to morphine

• history of central nervous system disease

• patients receiving a psychotropic treatment

• patients with a pace-maker

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Foch	Suresnes	Hauts de Seine	France	92151
2	Clinique Fontaine les Dijons	Fontaine les Dijon		France	21121

Sponsors and Collaborators

• Hopital Foch

Investigators

• Study Chair: Marc Fischler, MD, Hôpital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT02011347
• Other Study ID Numbers: 2012/26; 2012-003001-97
• First Posted: Dec 13, 2013
• Last Update Posted: Apr 6, 2017
• Last Verified: Apr 1, 2017

• Additional relevant MeSH terms: Ketamine

Study Results

No Results Posted as of Apr 6, 2017