Elective Laparoscopic CholecystectomyPhase 2NCT01571804
Pregabalin Reduce the Sevoflurane Requirement
A Phase 2 study testing pregabalin in people with Elective Laparoscopic Cholecystectomy and Sevoflurane Anesthesia, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men only
- Conditions the study is for
- Elective Laparoscopic Cholecystectomy, Sevoflurane Anesthesia
- What is being tested?
- pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2011to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists class I and II
- scheduled for elective laparoscopic cholecystectomy
- under sevoflurane anesthesia
Who cannot join
- communication barriers
- cardiovascular diseases
- renal diseases
- hepatic diseases
- endocrinal diseases
- neuropsychiatric diseases
Show all 11Show fewer
- prolonged P-R interval
- pregnancy
- nursing
- hypersensitivity
- treated by pregabalin, antidepressant, anticonvulsants, opiates or benzodiazepines during the last week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Pregabalin Reduce the Sevoflurane Requirement During Laparoscopic Cholecystectomy? Mansoura University Hospitals Experience.
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.
Read the detailed description
laparoscopic cholecystectomy is a painful and stressful surgical procedure. Pregabalin is a lipophilic structural analogue of the inhibitory γ-aminobutyric acid by binding to the presynaptic voltage-gated calcium channels that are widely distributed throughout the central and peripheral nervous system. Pregabalin has anticonvulsant, anxiolytic, sleep-modulating, anti-hyperalgesic, opioid-sparing6 and anti-allodynic properties through inhibition of the release of excitatory neurotransmitters such as glutamate, norepinephrine, serotonin, dopamine and substance P. These unique characteristics make pregabalin as a useful therapeutic for treating neuropathic pain and acute postoperative pain in several models of incisional injury and inflammatory conditions including laparoscopic cholecystectomy.
- Being tested
- Placebo, pregabalin
- Keywords
- Anesthesia, pregabalin, sevoflurane, laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
to receive two identical placebo capsules 1 hr before surgery
pregabalinDrug
one capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery
pregabalinDrug
two capsules of pregabalin 150 mg 1 hr before surgery
| Study group | Role | What they receive |
|---|---|---|
| pregabalin 150 mg group | Active comparator | one capsule of pregabalin 150 mg and one placebo capsule Receives: Drug: pregabalin |
| pregabalin 300 mg group | Active comparator | two capsules of pregabalin 150 mg Receives: Drug: pregabalin |
| placebo group | Placebo comparator | to receive two identical placebo capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative every 15 min
Secondary outcomes (7)
hemodynamic parameters
heart rate and mean arterial blood pressure were recorded before (baseline), 45 min after the administration of the study capsules; every 15 min after intubation until the skin closure and every 15 min for the first hour after extubation.
Measured: 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 fentanyl supplementations
Measured: intraoperative, an expected average of 2 hours
quality of tracheal extubation
The quality of tracheal extubation was evaluated using a 5 - points rating scale: 1, no coughing or straining; 2, very smooth, minimal coughing; 3, moderate coughing; 4, marked coughing or straining; and 5, poor extubation, very uncomfortable
Measured: up to 24 after surgery
postoperative cumulative morphine consumption
postoperative cumulative morphine consumption
Measured: up to 24 after surgery
postoperative sedation and pain scores
Postoperative pain VAS scores sedation (four-point verbal rating scores (VRS): awake, drowsy, rousable or deep sleep)
Measured: up to 24 after surgery
postoperative nausea and vomiting
nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting)
Measured: up to 24 after surgery
awareness and recall
The patients were asked about intraoperative awareness and recall on the second postoperative day by asking three simple questions using standard interview "What was the last thing you remembered happening before you went to sleep? What is the first thing you remember happening on waking? Did you dream or have any other experiences whilst you were asleep?"
Measured: intraoperative, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed R El Tahan, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571804
- Sponsor's protocol ID
- R/49
- Status last verified
- May 2012
- First submitted
- 31 Mar 2012
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pregabalin Reduce the Sevoflurane Requirement During Laparoscopic Cholecystectomy? Mansoura University Hospitals Experience.
- ClinicalTrials.gov ID
- NCT01571804
- Acronym / sponsor ID
- R/49
- Keywords
- Anesthesia, pregabalin, sevoflurane, laparoscopic cholecystectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
laparoscopic cholecystectomy is a painful and stressful surgical procedure. Pregabalin is a lipophilic structural analogue of the inhibitory γ-aminobutyric acid by binding to the presynaptic voltage-gated calcium channels that are widely distributed throughout the central and peripheral nervous system. Pregabalin has anticonvulsant, anxiolytic, sleep-modulating, anti-hyperalgesic, opioid-sparing6 and anti-allodynic properties through inhibition of the release of excitatory neurotransmitters such as glutamate, norepinephrine, serotonin, dopamine and substance P. These unique characteristics make pregabalin as a useful therapeutic for treating neuropathic pain and acute postoperative pain in several models of incisional injury and inflammatory conditions including laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pregabalin 150 mg group | Active comparator | Drug: pregabalinone capsule of pregabalin 150 mg and one placebo capsule |
| pregabalin 300 mg group | Active comparator | Drug: pregabalintwo capsules of pregabalin 150 mg |
| placebo group | Placebo comparator | Drug: Placeboto receive two identical placebo capsules |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists class I and II
- scheduled for elective laparoscopic cholecystectomy
- under sevoflurane anesthesia
Key exclusion criteria (11 listed)
- communication barriers
- cardiovascular diseases
- renal diseases
- hepatic diseases
- endocrinal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboto receive two identical placebo capsules 1 hr before surgery | Drug | placebo group |
| pregabalinone capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery | Drug | pregabalin 150 mg group |
| pregabalintwo capsules of pregabalin 150 mg 1 hr before surgery | Drug | pregabalin 300 mg group |
Primary outcome
changes in the end tidal sevoflurane concentrations
Time frame: intraoperative every 15 min
End-tidal concentrations of sevoflurane (Et-Sevo) were recorded every 15 min after intubation until the skin closure.
7 secondary outcomes
hemodynamic parameters
Time frame: before surgery, after the administration of the study capsules; intraoperative, an expected average of 2 hours, up to 24 after surgery
intraoperative fentanyl supplementations
Time frame: intraoperative, an expected average of 2 hours
quality of tracheal extubation
Time frame: up to 24 after surgery
postoperative cumulative morphine consumption
Time frame: up to 24 after surgery
postoperative sedation and pain scores
Time frame: up to 24 after surgery
postoperative nausea and vomiting
Time frame: up to 24 after surgery
awareness and recall
Time frame: intraoperative, an expected average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pregabalin in people with Elective Laparoscopic Cholecystectomy and Sevoflurane Anesthesia, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the end tidal sevoflurane concentrations (time frame: intraoperative every 15 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.