Pregabalin Reduce the Sevoflurane Requirement
Does Pregabalin Reduce the Sevoflurane Requirement During Laparoscopic Cholecystectomy? Mansoura University Hospitals Experience.
1 other identifier
interventional
42
1 country
1
Brief Summary
Preoperative administration of pregabalin would reduce the end tidal concentration of sevoflurane during laparoscopic cholecystectomy with added beneficial improving of the quality of postoperative analgesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 31, 2012
CompletedFirst Posted
Study publicly available on registry
April 5, 2012
CompletedMay 7, 2012
May 1, 2012
2 months
March 31, 2012
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in the end tidal sevoflurane concentrations
End-tidal concentrations of sevoflurane (Et-Sevo) were recorded every 15 min after intubation until the skin closure.
intraoperative every 15 min
Secondary Outcomes (7)
hemodynamic parameters
before surgery, after the administration of the study capsules; intraoperative, an expected average of 2 hours, up to 24 after surgery
intraoperative fentanyl supplementations
intraoperative, an expected average of 2 hours
quality of tracheal extubation
up to 24 after surgery
postoperative cumulative morphine consumption
up to 24 after surgery
postoperative sedation and pain scores
up to 24 after surgery
- +2 more secondary outcomes
Study Arms (3)
pregabalin 150 mg group
ACTIVE COMPARATORone capsule of pregabalin 150 mg and one placebo capsule
pregabalin 300 mg group
ACTIVE COMPARATORtwo capsules of pregabalin 150 mg
placebo group
PLACEBO COMPARATORto receive two identical placebo capsules
Interventions
one capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists class I and II
- scheduled for elective laparoscopic cholecystectomy
- under sevoflurane anesthesia
You may not qualify if:
- communication barriers
- cardiovascular diseases
- renal diseases
- hepatic diseases
- endocrinal diseases
- neuropsychiatric diseases
- prolonged P-R interval
- pregnancy
- nursing
- hypersensitivity
- treated by pregabalin, antidepressant, anticonvulsants, opiates or benzodiazepines during the last week
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University Hospitals
Al Mansurah, DK, 050, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 31, 2012
First Posted
April 5, 2012
Study Start
December 1, 2011
Primary Completion
February 1, 2012
Study Completion
March 1, 2012
Last Updated
May 7, 2012
Record last verified: 2012-05