Spine SurgeryNCT03301025
Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.
A study testing Pregabalin in people with Spine Surgery, run by Mansoura University at 2 sites in Egypt.
Trial summary
Elective lumbar spine surgical procedures are commonly performed under controlled hypotension during general anesthesia. That is beneficial to limit the intraoperative blood loss and transfusions and improves surgical field. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Spine Surgery
- 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
- 106 participants
- Where
- 2 sitesEgypt
- Study dates
- 8 Jan 2018to 30 Apr 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) score I-II
- admitted to undergo lumbar discectomy or spinal fixation surgery under general anesthesia
Who cannot join
- Patients on anti-hypertensive treatment, diuretics, corticosteroids, pregabalin, gabapentin, anticonvulsants, antipsychotics,
- alcohol addiction or drug abuse
- patients with history of allergy to any drug used in the study .
- pregnant or nursing women
- patients with peripheral neuropathy, endocrinal diseases, bleeding abnormality,
- cardiac, hepatic or renal impairment
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Delta Hospital
Al Mansurah, Dakahlia Governorate, 35516
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Elective lumbar spine surgical procedures are commonly performed under controlled hypotension during general anesthesia. That is beneficial to limit the intraoperative blood loss and transfusions and improves surgical field. Deliberate hypotension could be achieved via various medications but mostly associated with significant side effects. Pregabalin effectively augmented hypotensive anesthesia. The hypothesis is that Pregabalin 150 mg single preoperative dose may augment intraoperative deliberate hypotension that will be reflected on blood loss and nitroglycerin consumption.
Read the detailed description
An arterial line will be established then general anesthesia will be conducted. After adequate preoxygenation, anesthesia induction by IV fentanyl 1.5µg/kg, propofol 2 mg/kg, and atracurium 0.5 mg/kg then appropriated size tracheal tube. The ventilator settings will be adjusted to maintain the end-tidal carbon dioxide tension (ETco2) at 30-35 mm Hg. Anesthesia will be maintained by isoflurane concentration 1.2%, with 40% oxygen in air then IV infusion of fentanyl 0.05 mcg/kg/min was started while atracurium 0.1 mg/kg incremental dose as required. Then patients will be turned into the prone position above pad support permitting free hanging of the abdomen. Intraoperatively, the target mean arterial arterial blood pressure (MBP) is 55-65 mm Hg. After surgical incision, if MBP exceeds 65 mm Hg (defined as hypertension) it will be managed by: increasing isoflurane MAC up to 2%, if no response after 5 min, Nitroglycerin infusion initiated at 0.5 mcg/kg/min to 40 mcg/kg/min. Hypotension (MBP <55 mm Hg) will be treated by stopping nitroglycerin, proper compensation of losses, reducing Isoflurane MAC. If persisted; vasoactive drugs will be used. Bradycardia (HR <50 beat/min.), treated with 0.01 mg/kg atropine IV increments.
The nitroglycerin infusion will be stopped after the finial surgical hemostasis. Fentanyl infusion will be stopped before ligament sutures. Isoflurane will be closed after the last surgical suture. After dressing, patient will be turned to the supine position and morphine 0.025 mg/kg IV will be administered then 0.04 mg/kg neostigmine and 0.015 mg/kg atropine for reversal. Extubation will be done after establishment of acceptable spontaneous respiration.
- Conditions
- Spine Surgery
- Being tested
- Pregabalin, placebo
- Keywords
- Pregabalin, hypotensive anesthesia, blood loss, analgesia
- Medical subject headings
- Hemorrhage, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called (LYRICA® 150 mg capsule- PFIZER)
Pregabalin 150 mg capsule, one h preinduction of general anesthesia
placeboDrug
Also called control
given a placebo identical capsule once one hour before anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin group | Active comparator | (n=53): Receives: Drug: Pregabalin |
| placebo group | Placebo comparator | (n=53): Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nitroglycerin consumption
the total nitroglycerin consumption in milligram to maintain the target mean arterial pressure (MAP) 55- 65 mmHg.
Measured: Intraoperative
Secondary outcomes (12)
Estimated blood loss
towels are weighted, plus suction volume without irrigation fluids in milliter.
Measured: intraoperative
The number of transfused blood unites
Packed red blood cell unites
Measured: intraoperative
heart rate (HR)
in beat/min
Measured: Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.
end-tidal isoflurane concentration
in percent
Measured: at 30, 60, 90, 120, 150 , 180, 210 minutes after intubation.
Surgeon satisfaction about the field
using a six-point scale (0 = no bleeding, virtually bloodless field; 5 = uncontrolled) bleeding).
Measured: within 2 hours from the end of surgery.
Sedation
(Ramsay sedation scale)
Measured: at 0, 2, 4, 6, 12, 24 hours postoperatively
The time to the first request of analgesia.
in hours
Measured: 24 hours postoperative
Postoperative pain
(VAS 0-10 scale) 10 is the worst pain
Measured: at 0, 2, 4, 6, 12, 24 hours postoperatively.
The total morphine consumption
in mg
Measured: in the 1st 24 hours postoperatively
Frequency of adverse effects
dizziness, headache, nausea and vomiting, or pruritus.
Measured: during the first 24 hours postoperatively
Peak airway pressures
in centimeter water
Measured: 10 minutes after settled prone position
invasive mean arterial blood pressure (MAP)
in millimeter mercury (mmHg)
Measured: Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start8 Jan 2018
- Primary completion30 Mar 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mazy Mazy, Mansoura University
- Investigators
- Alaa Mazy, Principal investigator, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301025
- Sponsor's protocol ID
- R/17.07.107
- Status last verified
- Sep 2020
- First submitted
- 26 Sep 2017
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be available after about 6 months
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.
- ClinicalTrials.gov ID
- NCT03301025
- Acronym / sponsor ID
- R/17.07.107
- Conditions
- Spine Surgery
- Keywords
- Pregabalin, hypotensive anesthesia, blood loss, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 4 Oct 2017 (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.
Elective lumbar spine surgical procedures are commonly performed under controlled hypotension during general anesthesia. That is beneficial to limit the intraoperative blood loss and transfusions and improves surgical field. Deliberate hypotension could be achieved via various medications but mostly associated with significant side effects. Pregabalin effectively augmented hypotensive anesthesia. The hypothesis is that Pregabalin 150 mg single preoperative dose may augment intraoperative deliberate hypotension that will be reflected on blood loss and nitroglycerin consumption.
Detailed description
An arterial line will be established then general anesthesia will be conducted. After adequate preoxygenation, anesthesia induction by IV fentanyl 1.5µg/kg, propofol 2 mg/kg, and atracurium 0.5 mg/kg then appropriated size tracheal tube. The ventilator settings will be adjusted to maintain the end-tidal carbon dioxide tension (ETco2) at 30-35 mm Hg. Anesthesia will be maintained by isoflurane concentration 1.2%, with 40% oxygen in air then IV infusion of fentanyl 0.05 mcg/kg/min was started while atracurium 0.1 mg/kg incremental dose as required. Then patients will be turned into the prone position above pad support permitting free hanging of the abdomen. Intraoperatively, the target mean arterial arterial blood pressure (MBP) is 55-65 mm Hg. After surgical incision, if MBP exceeds 65 mm Hg (defined as hypertension) it will be managed by: increasing isoflurane MAC up to 2%, if no response after 5 min, Nitroglycerin infusion initiated at 0.5 mcg/kg/min to 40 mcg/kg/min. Hypotension (MBP <55 mm Hg) will be treated by stopping nitroglycerin, proper compensation of losses, reducing Isoflurane MAC. If persisted; vasoactive drugs will be used. Bradycardia (HR <50 beat/min.), treated with 0.01 mg/kg atropine IV increments.
The nitroglycerin infusion will be stopped after the finial surgical hemostasis. Fentanyl infusion will be stopped before ligament sutures. Isoflurane will be closed after the last surgical suture. After dressing, patient will be turned to the supine position and morphine 0.025 mg/kg IV will be administered then 0.04 mg/kg neostigmine and 0.015 mg/kg atropine for reversal. Extubation will be done after establishment of acceptable spontaneous respiration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin group | Active comparator | Drug: Pregabalin(n=53): |
| placebo group | Placebo comparator | Drug: placebo(n=53): |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) score I-II
- admitted to undergo lumbar discectomy or spinal fixation surgery under general anesthesia
Key exclusion criteria (6 listed)
- Patients on anti-hypertensive treatment, diuretics, corticosteroids, pregabalin, gabapentin, anticonvulsants, antipsychotics,
- alcohol addiction or drug abuse
- patients with history of allergy to any drug used in the study .
- pregnant or nursing women
- patients with peripheral neuropathy, endocrinal diseases, bleeding abnormality,
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 |
|---|---|---|
| PregabalinAlso: (LYRICA® 150 mg capsule- PFIZER)Pregabalin 150 mg capsule, one h preinduction of general anesthesia | Drug | Pregabalin group |
| placeboAlso: controlgiven a placebo identical capsule once one hour before anesthesia | Drug | placebo group |
Primary outcome
Nitroglycerin consumption
Time frame: Intraoperative
the total nitroglycerin consumption in milligram to maintain the target mean arterial pressure (MAP) 55- 65 mmHg.
12 secondary outcomes
Estimated blood loss
Time frame: intraoperative
The number of transfused blood unites
Time frame: intraoperative
heart rate (HR)
Time frame: Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.
end-tidal isoflurane concentration
Time frame: at 30, 60, 90, 120, 150 , 180, 210 minutes after intubation.
Surgeon satisfaction about the field
Time frame: within 2 hours from the end of surgery.
Sedation
Time frame: at 0, 2, 4, 6, 12, 24 hours postoperatively
The time to the first request of analgesia.
Time frame: 24 hours postoperative
Postoperative pain
Time frame: at 0, 2, 4, 6, 12, 24 hours postoperatively.
The total morphine consumption
Time frame: in the 1st 24 hours postoperatively
Frequency of adverse effects
Time frame: during the first 24 hours postoperatively
Peak airway pressures
Time frame: 10 minutes after settled prone position
invasive mean arterial blood pressure (MAP)
Time frame: Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 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 18 Sep 2020.
- Individual participant dataSharing planned: Yes. all data will be available after about 6 months
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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.
Alaa Mazy principal investigator
Faculty of Medicine, Mansoura University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin in people with Spine Surgery, run by Mansoura University at 2 sites 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 2 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Nitroglycerin consumption (time frame: Intraoperative). 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 18 Sep 2020.