Cerebral TumorNCT02306278
The Effects of Gabapentin Premedication on Neurosurgery
A study testing gabapentin and vitamin capsules in people with Cerebral Tumor, run by Capital Medical University at 1 site in China.
Trial summary
The study is to observe the effects of gabapentin premedication on postoperative pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are randomized into groups gabapentin(GG) or placebo(GP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Tumor
- What is being tested?
- gabapentin and vitamin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2014to Jun 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old, ASA physical status I or II, BMI<30
- Scheduled for elective craniotomy
- Cooperative and given informed consent in person
Who cannot join
- History of mental or psychiatric disorders
- Pregnant or lactating female
- History of systemic malignant tumor or diabetes
- Previously treated with this protocol or participated in another experimental study within previous 30 days
- Suspected history of allergic reaction or intolerance to gabapentin or other anesthetic agents in this study
- History of alcohol abuse and/or drug abuse within previous one year
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: The Effects of Gabapentin Premedication on Postoperative Pain,Nausea,Vomiting and Sedation in Patients Undergoing Neurosurgery
The study is to observe the effects of gabapentin premedication on postoperative pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are randomized into groups gabapentin(GG) or placebo(GP). Patients are given gabapentin or placebo orally the night before operation day and 2hours before surgery,respectively.The investigators hypothesized that lower incidence of postoperative pain,vomiting and nausea be observed in GG than GP.
Read the detailed description
This is a random, double-blind study. In GG, patients are given gabapentin 600mg orally at the night and 2hours before surgery, respectively. In PG, vitamine pills are given instead.Total intravenous anesthesia is applied for all patients. 1hour, 2hours,1day, 2days, 3months and 6months after surgery, patients are evaluated for pain (VAS) and incidence of PONV. In addition,Glasgow Score, Ramsay Score and other gabapentin-related effects, such as somnolence,dizzy or dry mouth are also observed.The incidence of persistent pain and neuropathic pain was assessed at the 3-mo and 6-mo postoperative evaluation.
- Conditions
- Cerebral Tumor
- Being tested
- gabapentin, vitamin capsules
- Keywords
- gabapentin, postoperative pain, vomiting, nausea
- Medical subject headings
- Pain, Postoperative, Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentinDrug
gabapentin capsules 0.3g
vitamin capsulesDrug
vitamin B
| Study group | Role | What they receive |
|---|---|---|
| vitamin capsules | Placebo comparator | vitamin capsules orally at the night before operation and 2 hours before surgery,respectively Receives: Drug: vitamin capsules |
| gabapentin | Experimental | gabapentin 600mg orally at the night before operation and 2 hours before surgery,respectively Receives: Drug: gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premedication gabapentin can decrease pain in early postoperative period
postoperative pain scores(Visual Analogue Scale)
Measured: 24 hour after extubation
Secondary outcomes (2)
Premedication gabapentin can limit the development of persistent pain and neuropathic pain.
postoperative pain scores(Visual Analogue Scale) and the Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale
Measured: 3-mos and 6-mos after surgery
Preoperative gabapentin can lead to a decrease incidence of PONV
Incidence of PONV
Measured: 1 hour,2 hours,1day,2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study start14 Dec 2014
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral TumorStudies of the same condition, open and under way.
- More trials run by Capital Medical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Capital Medical University
- Investigators
- Ru Quan Han, chief, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306278
- Sponsor's protocol ID
- ky2013-008-01
- Status last verified
- Oct 2017
- First submitted
- 16 Apr 2014
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Gabapentin Premedication on Postoperative Pain,Nausea,Vomiting and Sedation in Patients Undergoing Neurosurgery
- ClinicalTrials.gov ID
- NCT02306278
- Acronym / sponsor ID
- ky2013-008-01
- Conditions
- Cerebral Tumor
- Keywords
- gabapentin, postoperative pain, vomiting, nausea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 14 Dec 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Dec 2014 (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.
The study is to observe the effects of gabapentin premedication on postoperative pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are randomized into groups gabapentin(GG) or placebo(GP). Patients are given gabapentin or placebo orally the night before operation day and 2hours before surgery,respectively.The investigators hypothesized that lower incidence of postoperative pain,vomiting and nausea be observed in GG than GP.
Detailed description
This is a random, double-blind study. In GG, patients are given gabapentin 600mg orally at the night and 2hours before surgery, respectively. In PG, vitamine pills are given instead.Total intravenous anesthesia is applied for all patients. 1hour, 2hours,1day, 2days, 3months and 6months after surgery, patients are evaluated for pain (VAS) and incidence of PONV. In addition,Glasgow Score, Ramsay Score and other gabapentin-related effects, such as somnolence,dizzy or dry mouth are also observed.The incidence of persistent pain and neuropathic pain was assessed at the 3-mo and 6-mo postoperative evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin capsules | Placebo comparator | Drug: vitamin capsulesvitamin capsules orally at the night before operation and 2 hours before surgery,respectively |
| gabapentin | Experimental | Drug: gabapentingabapentin 600mg orally at the night before operation and 2 hours before surgery,respectively |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years old, ASA physical status I or II, BMI<30
- Scheduled for elective craniotomy
- Cooperative and given informed consent in person
Key exclusion criteria (6 listed)
- History of mental or psychiatric disorders
- Pregnant or lactating female
- History of systemic malignant tumor or diabetes
- Previously treated with this protocol or participated in another experimental study within previous 30 days
- Suspected history of allergic reaction or intolerance to gabapentin or other anesthetic agents in this study
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 |
|---|---|---|
| gabapentingabapentin capsules 0.3g | Drug | gabapentin |
| vitamin capsulesvitamin B | Drug | vitamin capsules |
Primary outcome
Premedication gabapentin can decrease pain in early postoperative period
Time frame: 24 hour after extubation
postoperative pain scores(Visual Analogue Scale)
2 secondary outcomes
Premedication gabapentin can limit the development of persistent pain and neuropathic pain.
Time frame: 3-mos and 6-mos after surgery
Preoperative gabapentin can lead to a decrease incidence of PONV
Time frame: 1 hour,2 hours,1day,2 days after surgery
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 16 Oct 2017.
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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.
Ru Quan Han, chief study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gabapentin and vitamin capsules in people with Cerebral Tumor, run by Capital Medical University at 1 site in China.
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 6 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 16 Oct 2017. 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 China. 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.
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?
Premedication gabapentin can decrease pain in early postoperative period (time frame: 24 hour after extubation). 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 16 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.