Knee ArthroscopyNCT03926000
Pregabalin Premedication for Knee Arthroscopy
A study testing Pregabalin (PG) in people with Knee Arthroscopy, run by Menoufia University.
Trial summary
Outpatient arthroscopic knee surgery can be performed with general or regional anesthesia. Recent data suggest that spinal and epidural anesthesia require longer discharge times than the newer shorter-acting general anesthetic drugs. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Knee Arthroscopy
- What is being tested?
- Pregabalin (PG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Dec 2019
- Phase
- Interventional
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for elective knee arthroscopy.
- Patients aged between 21 and 50 years old.
- Patients with American Society of Anaesthesiologists physical status I or II.
Who cannot join
- Patients with known allergy to any drug used in the study.
- Patients with chronic use of analgesics and/or sedatives.
- Patients with sleep apnea syndrome.
- Patients with renal or hepatic dysfunction.
- Patients with psychiatric disorders.
About this study
Official title: The Effect of Pregabalin Premedication on Anaesthetic Requirements and Recovery Time After Knee Arthroscopy
Outpatient arthroscopic knee surgery can be performed with general or regional anesthesia. Recent data suggest that spinal and epidural anesthesia require longer discharge times than the newer shorter-acting general anesthetic drugs. Ideal premedication drug should relieve anxiety, produce amnesia and sedation, decrease secretions, prevent nausea and vomiting, have dose sparing effect on the anaesthetic drugs, and suppress pressor response to laryngoscopy and intubation. Recently, gabapentin and pregabalin were suggested as pre-operative drugs to decrease anxiety, stress response to laryngoscopy and post operative pain.
Read the detailed description
112 patients undergoing elective knee arthroscopy will randomly divided into two equal groups, 56 patients each. All patients will receive premedication one hour before the procedure. PG group will receive 150 mg pregabalin and C group will receive placebo. All patients will receive total intravenous anesthesia to achieve optimum working conditions. Intra-operative total amount of anesthetics will be compared in both groups.
- Conditions
- Knee Arthroscopy
- Being tested
- Pregabalin (PG), Control placebo (C)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin (PG)Drug
Also called Pregabalin for premedication
Pregabalin 150 mg one hour before the procedure as premedication.
Control placebo (C)Drug
Also called Placebo for premeditation.
Placebo tablets one hour before the procedure as premedication.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin (PG) | Active comparator | Patients will receive 150 mg pregabalin one hour before the procedure. Receives: Drug: Pregabalin (PG) |
| Control placebo (C) | Placebo comparator | Patients will receive placebo tablet one hour before surgery. Receives: Drug: Control placebo (C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of anesthetics
Total amount of anesthetics used during the procedure.
Measured: 45 minutes during the procedure
Secondary outcomes (1)
Patients' satisfaction: satisfaction score
Patient's satisfaction score will be recorded using a score ranging from 0 not satisfied and 5 totally satisfied. The score will be done using a questioner designed by the researchers.
Measured: 30 minutes after the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study startJun 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroscopyStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ezzeldin Ibrahim, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926000
- Sponsor's protocol ID
- MenoufiaU2019/7
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pregabalin Premedication on Anaesthetic Requirements and Recovery Time After Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT03926000
- Acronym / sponsor ID
- MenoufiaU2019/7
- Conditions
- Knee Arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 Apr 2019 (actual)
- 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.
Outpatient arthroscopic knee surgery can be performed with general or regional anesthesia. Recent data suggest that spinal and epidural anesthesia require longer discharge times than the newer shorter-acting general anesthetic drugs. Ideal premedication drug should relieve anxiety, produce amnesia and sedation, decrease secretions, prevent nausea and vomiting, have dose sparing effect on the anaesthetic drugs, and suppress pressor response to laryngoscopy and intubation. Recently, gabapentin and pregabalin were suggested as pre-operative drugs to decrease anxiety, stress response to laryngoscopy and post operative pain.
Detailed description
112 patients undergoing elective knee arthroscopy will randomly divided into two equal groups, 56 patients each. All patients will receive premedication one hour before the procedure. PG group will receive 150 mg pregabalin and C group will receive placebo. All patients will receive total intravenous anesthesia to achieve optimum working conditions. Intra-operative total amount of anesthetics will be compared in both groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin (PG) | Active comparator | Drug: Pregabalin (PG)Patients will receive 150 mg pregabalin one hour before the procedure. |
| Control placebo (C) | Placebo comparator | Drug: Control placebo (C)Patients will receive placebo tablet one hour before surgery. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective knee arthroscopy.
- Patients aged between 21 and 50 years old.
- Patients with American Society of Anaesthesiologists physical status I or II.
Key exclusion criteria (5 listed)
- Patients with known allergy to any drug used in the study.
- Patients with chronic use of analgesics and/or sedatives.
- Patients with sleep apnea syndrome.
- Patients with renal or hepatic dysfunction.
- Patients with psychiatric disorders.
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 |
|---|---|---|
| Pregabalin (PG)Also: Pregabalin for premedicationPregabalin 150 mg one hour before the procedure as premedication. | Drug | Pregabalin (PG) |
| Control placebo (C)Also: Placebo for premeditation.Placebo tablets one hour before the procedure as premedication. | Drug | Control placebo (C) |
Primary outcome
Total amount of anesthetics
Time frame: 45 minutes during the procedure
Total amount of anesthetics used during the procedure.
1 secondary outcome
Patients' satisfaction: satisfaction score
Time frame: 30 minutes after the end of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin (PG) in people with Knee Arthroscopy, run by Menoufia University.
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 5 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: status not confirmed, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Total amount of anesthetics (time frame: 45 minutes during the procedure). 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 25 Apr 2019.