Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| KETAMINE | Other Identifier | Institut Bergonié |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. The purpose is to evaluate the analgesic effect of a receptor NMDA's antagonist ( ketamine)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine Arm | Experimental | Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol". |
|
| Reference Arm | Sham Comparator | Induction and anesthetic maintenance without ketamine (reference arm / saline solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug |
| ||
| Saline solution |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Consumption (First 48 Post-operative Hours) | Number of participants with at least one consumption of morphine within 48 hours following surgery. | within 48 hours following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain | Count of participants with post-operative pain. Pain was measured using a Visual Analog Rating Scale (VAS), ranging from 0 (no pain) to 10 (pain). A VAS score >= 4 wwas considered as "Pain". A VAS sore <4 was considered as "No pain". | 48 hours after surgery |
Not provided
Inclusion criteria:
Exclusion criteria:
.Kétamine hypersensitivity
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sylvie COLOMBANI, MD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest | Bordeaux | 33076 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine Arm | Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol". Ketamine |
| FG001 | Reference Arm | Induction and anesthetic maintenance without ketamine (reference arm / saline solution) Saline solution |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine Arm | Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol". Ketamine |
| BG001 | Reference Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morphine Consumption (First 48 Post-operative Hours) | Number of participants with at least one consumption of morphine within 48 hours following surgery. | Posted | Count of Participants | Participants | within 48 hours following surgery |
|
6 months after surgery
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine Arm | Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol". Ketamine |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trials' Unit | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33 5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D001943 | Breast Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Induction and anesthetic maintenance without ketamine (reference arm / saline solution)
Saline solution
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Post-operative Pain | Count of participants with post-operative pain. Pain was measured using a Visual Analog Rating Scale (VAS), ranging from 0 (no pain) to 10 (pain). A VAS score >= 4 wwas considered as "Pain". A VAS sore <4 was considered as "No pain". | Posted | Count of Participants | Participants | 48 hours after surgery |
|
|
|
| 0 |
| 109 |
| 0 |
| 109 |
| 20 |
| 109 |
| EG001 | Reference Arm | Induction and anesthetic maintenance without ketamine (reference arm / saline solution) Saline solution | 0 | 104 | 0 | 104 | 14 | 104 |
| Vomiting NOS | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |