MalondialdehydeNCT05950555
The Effects of Two Anesthetic Drugs on Some Enzyme Levels in Patients Undergoing Lower Extremity Surgery
A study testing Saline, Dexmedetomidine and Ketamine in people with Malondialdehyde and Heme Oxygenase, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to compare the effects of dexmedetomidine and ketamine, which are administered intravenously during surgery, on the levels of malondialdehyde, an antioxidant, anti-inflammatory enzyme, heme oxygenase-1 enzyme levels and C-reactive protein levels in patients who underwent lower… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malondialdehyde, Heme Oxygenase, C-Reactive Protein
- What is being tested?
- Saline, Dexmedetomidine and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2021to 28 May 2023
- 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
- ASA risk classification 1-2
- Patients who agreed to participate in the study
Who cannot join
- Body mass index (BMI) over 30 kg/m2
- Patients who will use bone cement in the surgical procedure
- Patients who will apply a tourniquet to the lower extremity
- Patients with vascular and coronary disease
- Patients with coagulation disorders that would prevent the application of CSEA
- Patients with allergies to the drugs to be used in the study
Show all 10Show fewer
- Patients with increased head and intraocular pressure
- Patients with psychiatric and neuromuscular disorders
- Patients with multiple trauma
- Patients who did not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind Comparison of the Effects of Dexmedetomidine and Ketamine on Oxidative Stress Markers in Patients Under Combined Spinal-epidural Anesthesia Under Lower Extremity Surgery
The primary aim of this study was to compare the effects of dexmedetomidine and ketamine, which are administered intravenously during surgery, on the levels of malondialdehyde, an antioxidant, anti-inflammatory enzyme, heme oxygenase-1 enzyme levels and C-reactive protein levels in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
Read the detailed description
This study was planned as double-blind; The researcher who evaluated the patient and recorded the data did not know which group the patient belonged to. The randomization sequence was generated with a computerized random number generator and patients were assigned to 3 groups, with 30 patients in each group.
The group to which the patient was included was listed in serially numbered sealed opaque envelopes. Another investigator (not involved in this study and not blinded to group assignment) administered CSEA to patients in a sitting position and opened the envelopes to see which group the patient belonged to, and prepared and administered the drugs to be used during anesthesia. An anesthetist, blinded to the group allocation, was responsible for collecting the intraoperative data. During and after surgery, data were recorded by and by this investigator. The blood of the patients was taken by the researcher who collected the data and delivered to the researchers who made the biochemical analyzes of their blood and blinded the groups. All surgeries were performed by the same surgical team and the same anesthesia team.
Peripheral IV vascular access was established using a 16/18-gauge cannula on the day of the operation. No premedication was applied to any patient before the operation. Before the anesthesia procedure, the patients' age, weight, height, body mass indexes, american society of anesthesiologists (ASA) physical status, systolic, diastolic and mean blood pressure baseline values, heart rate and oxygen saturation levels were recorded.
CSEA was applied to all patients in the sitting position. Following skin sterilization and local anesthetic infiltration (2% lidocaine), an 18-gauge Tuohy needle (CSEA, Braun, Melsungen, Germany) was advanced along the midline L3-4 or L4-5 intervertebral spaces using a loss of resistance technique. After negative pressure was detected, a 27-gauge pen-tipped spinal needle was inserted intrathecally using the needle-through-the-needle technique. After the free cerebrospinal fluid flow was observed, 1.8 ml 0.5% isobaric bupivacaine (9 mg) and 15 µg fentanyl were administered for 30 seconds. Then, the spinal needle was removed and the catheter was inserted into the epidural space, and it was advanced 3-5 cm in the space and controlled with negative pressure, and the catheter was fixed. At the end of the anesthesia procedure, the patients were placed in the supine position for the operation. The necessary study drugs were started to be administered to the patients in accordance with the study group they were assigned to, and infusions were continued throughout the operation.
The level of sensory block was assessed with the pinprick test, and surgery was allowed when the sensory block reached the upper level of the T12-L1 dermatome. If sensory block did not occur within the first 20 minutes following the spinal injection, spinal anesthesia was considered unsuccessful and the patients were excluded from the study. The patients who were excluded from the study were injected with an additional 5 ml of 2% lidocaine solutions through the epidural catheter until the sensory block T12-L1 level was achieved, and the patients were allowed to operate.
If the intrathecal space could not be reached in three unsuccessful attempts, a general anesthesia protocol was planned and patients requiring general anesthesia were excluded from the study.
For the measurement of MDA and HO-1 levels, blood samples taken from the patient groups included in the study were taken for 10-20 minutes for clotting. After the tube was kept in an upright position, it was centrifuged at +4°C at 4000 rpm for 15 minutes. The serum samples obtained were aliquoted and placed in a deep freezer at -80˚Ϲ and kept there until the day of analysis.
Serum malondialdehyde (MDA) and HO-1 levels were measured on the same day in order not to be affected by the variation between days. Serum MDA and HO-1 levels were determined by ELISA method, using "Human MDA ELISA Kit" and Human HO-1 ELISA Kit. measured in accordance with the manufacturer's instructions.
In addition, C-reactive protein (CRP) (mg/dl), calcium (mg/dl), alkaline phosphatase (U/L), lactate dehydrogenase (U/L), aspartate aminotransferase (U/L), alanine aminotransferase, which are routinely checked at preoperative, postoperative 2nd and 24th hours. (U/L), glucose (mg/dl), potassium (nmol/L), iron (ug/dl), total protein (g/dl) and albumin (g/dl) levels in Beckman Coulter device, ferritin (ng) /ml) Beckman Coulter device, Blood count parameters, White Blood Cell Count (10^3/mcL), Total Lymphocyte Count (10^3/mcL), Hemoglobin (g/dL) were studied on Sysmex device.
- Conditions
- Malondialdehyde, Heme Oxygenase, C-Reactive Protein
- Being tested
- Saline, Dexmedetomidine, Ketamine
- Keywords
- Ketamine, Dexmedetomidine, Oxidative Stress, Antioxidant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineOther
We used 0.9% isotonic sodium chloride.
DexmedetomidineOther
We used the vial containing 200 mcg/2 ml i.v. concentrated infusion solution in 100 ml of 0.9% isotonic sodium chloride.
KetamineOther
We used 500 mg/10 ml solution for injection in 0.9% isotonic sodium chloride.
| Study group | Role | What they receive |
|---|---|---|
| Patients given saline | Active comparator | 10 cc/hour isotonic is given throughout the operation. Receives: Other: Saline |
| Patients given dexmedetomidine. | Active comparator | Dexmedetomidine 0.1 µg/kg IV bolus followed by 0.2 µg/kg/hr infusion throughout surgery. Receives: Other: Dexmedetomidine |
| Patients given ketamine. | Active comparator | Ketamine 0.2 mg/kg bolus followed by 0.1 mg/kg/hr infusion throughout surgery. Receives: Other: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Malondialdehyde
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of malondialdehyde, which is an oxidative stress marker, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
Measured: just before surgery
Heme Oxygenase-1
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of heme oxygenase-1, an antioxidant and anti-inflammatory enzyme, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
Measured: just before surgery
C-Reactive Protein
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on C-Reactive Protein in patients undergoing lower extremity surgery under combined spinal epidural anesthesia.
Measured: just before surgery
Malondialdehyde
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of malondialdehyde, which is an oxidative stress marker, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
Measured: 2 hours after the start of surgery
Heme Oxygenase-1
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of heme oxygenase-1, an antioxidant and anti-inflammatory enzyme, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
Measured: 2 hours after the start of surgery
C-Reactive Protein
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on C-Reactive Protein in patients undergoing lower extremity surgery under combined spinal epidural anesthesia.
Measured: 2 hours after the start of surgery
Malondialdehyde
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of malondialdehyde, which is an oxidative stress marker, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
Measured: 24 hours after surgery
Heme Oxygenase-1
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of heme oxygenase-1, an antioxidant and anti-inflammatory enzyme, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
Measured: 24 hours after surgery
C-Reactive Protein
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on C-Reactive Protein in patients undergoing lower extremity surgery under combined spinal epidural anesthesia.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start30 Dec 2021
- Primary completion30 Mar 2023
- Study completion28 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalondialdehydeStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet AKSOY, Ataturk University
- Investigators
- İrfan Uç, Principal investigator, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950555
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/23
- Status last verified
- Aug 2023
- First submitted
- 5 Jun 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will decide later.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Comparison of the Effects of Dexmedetomidine and Ketamine on Oxidative Stress Markers in Patients Under Combined Spinal-epidural Anesthesia Under Lower Extremity Surgery
- ClinicalTrials.gov ID
- NCT05950555
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/23
- Conditions
- Malondialdehyde, Heme Oxygenase, C-Reactive Protein
- Keywords
- Ketamine, Dexmedetomidine, Oxidative Stress, Antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 18 Jul 2023 (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.
The primary aim of this study was to compare the effects of dexmedetomidine and ketamine, which are administered intravenously during surgery, on the levels of malondialdehyde, an antioxidant, anti-inflammatory enzyme, heme oxygenase-1 enzyme levels and C-reactive protein levels in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
Detailed description
This study was planned as double-blind; The researcher who evaluated the patient and recorded the data did not know which group the patient belonged to. The randomization sequence was generated with a computerized random number generator and patients were assigned to 3 groups, with 30 patients in each group.
The group to which the patient was included was listed in serially numbered sealed opaque envelopes. Another investigator (not involved in this study and not blinded to group assignment) administered CSEA to patients in a sitting position and opened the envelopes to see which group the patient belonged to, and prepared and administered the drugs to be used during anesthesia. An anesthetist, blinded to the group allocation, was responsible for collecting the intraoperative data. During and after surgery, data were recorded by and by this investigator. The blood of the patients was taken by the researcher who collected the data and delivered to the researchers who made the biochemical analyzes of their blood and blinded the groups. All surgeries were performed by the same surgical team and the same anesthesia team.
Peripheral IV vascular access was established using a 16/18-gauge cannula on the day of the operation. No premedication was applied to any patient before the operation. Before the anesthesia procedure, the patients' age, weight, height, body mass indexes, american society of anesthesiologists (ASA) physical status, systolic, diastolic and mean blood pressure baseline values, heart rate and oxygen saturation levels were recorded.
CSEA was applied to all patients in the sitting position. Following skin sterilization and local anesthetic infiltration (2% lidocaine), an 18-gauge Tuohy needle (CSEA, Braun, Melsungen, Germany) was advanced along the midline L3-4 or L4-5 intervertebral spaces using a loss of resistance technique. After negative pressure was detected, a 27-gauge pen-tipped spinal needle was inserted intrathecally using the needle-through-the-needle technique. After the free cerebrospinal fluid flow was observed, 1.8 ml 0.5% isobaric bupivacaine (9 mg) and 15 µg fentanyl were administered for 30 seconds. Then, the spinal needle was removed and the catheter was inserted into the epidural space, and it was advanced 3-5 cm in the space and controlled with negative pressure, and the catheter was fixed. At the end of the anesthesia procedure, the patients were placed in the supine position for the operation. The necessary study drugs were started to be administered to the patients in accordance with the study group they were assigned to, and infusions were continued throughout the operation.
The level of sensory block was assessed with the pinprick test, and surgery was allowed when the sensory block reached the upper level of the T12-L1 dermatome. If sensory block did not occur within the first 20 minutes following the spinal injection, spinal anesthesia was considered unsuccessful and the patients were excluded from the study. The patients who were excluded from the study were injected with an additional 5 ml of 2% lidocaine solutions through the epidural catheter until the sensory block T12-L1 level was achieved, and the patients were allowed to operate.
If the intrathecal space could not be reached in three unsuccessful attempts, a general anesthesia protocol was planned and patients requiring general anesthesia were excluded from the study.
For the measurement of MDA and HO-1 levels, blood samples taken from the patient groups included in the study were taken for 10-20 minutes for clotting. After the tube was kept in an upright position, it was centrifuged at +4°C at 4000 rpm for 15 minutes. The serum samples obtained were aliquoted and placed in a deep freezer at -80˚Ϲ and kept there until the day of analysis.
Serum malondialdehyde (MDA) and HO-1 levels were measured on the same day in order not to be affected by the variation between days. Serum MDA and HO-1 levels were determined by ELISA method, using "Human MDA ELISA Kit" and Human HO-1 ELISA Kit. measured in accordance with the manufacturer's instructions.
In addition, C-reactive protein (CRP) (mg/dl), calcium (mg/dl), alkaline phosphatase (U/L), lactate dehydrogenase (U/L), aspartate aminotransferase (U/L), alanine aminotransferase, which are routinely checked at preoperative, postoperative 2nd and 24th hours. (U/L), glucose (mg/dl), potassium (nmol/L), iron (ug/dl), total protein (g/dl) and albumin (g/dl) levels in Beckman Coulter device, ferritin (ng) /ml) Beckman Coulter device, Blood count parameters, White Blood Cell Count (10^3/mcL), Total Lymphocyte Count (10^3/mcL), Hemoglobin (g/dL) were studied on Sysmex device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients given saline | Active comparator | Other: Saline10 cc/hour isotonic is given throughout the operation. |
| Patients given dexmedetomidine. | Active comparator | Other: DexmedetomidineDexmedetomidine 0.1 µg/kg IV bolus followed by 0.2 µg/kg/hr infusion throughout surgery. |
| Patients given ketamine. | Active comparator | Other: KetamineKetamine 0.2 mg/kg bolus followed by 0.1 mg/kg/hr infusion throughout surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA risk classification 1-2
- Patients who agreed to participate in the study
Key exclusion criteria (10 listed)
- Body mass index (BMI) over 30 kg/m2
- Patients who will use bone cement in the surgical procedure
- Patients who will apply a tourniquet to the lower extremity
- Patients with vascular and coronary disease
- Patients with coagulation disorders that would prevent the application of CSEA
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 |
|---|---|---|
| SalineWe used 0.9% isotonic sodium chloride. | Other | Patients given saline |
| DexmedetomidineWe used the vial containing 200 mcg/2 ml i.v. concentrated infusion solution in 100 ml of 0.9% isotonic sodium chloride. | Other | Patients given dexmedetomidine. |
| KetamineWe used 500 mg/10 ml solution for injection in 0.9% isotonic sodium chloride. | Other | Patients given ketamine. |
Primary outcome
Concentration of Malondialdehyde
Time frame: just before surgery
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of malondialdehyde, which is an oxidative stress marker, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
Heme Oxygenase-1
Time frame: just before surgery
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of heme oxygenase-1, an antioxidant and anti-inflammatory enzyme, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
C-Reactive Protein
Time frame: just before surgery
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on C-Reactive Protein in patients undergoing lower extremity surgery under combined spinal epidural anesthesia.
Malondialdehyde
Time frame: 2 hours after the start of surgery
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of malondialdehyde, which is an oxidative stress marker, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
Heme Oxygenase-1
Time frame: 2 hours after the start of surgery
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of heme oxygenase-1, an antioxidant and anti-inflammatory enzyme, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
C-Reactive Protein
Time frame: 2 hours after the start of surgery
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on C-Reactive Protein in patients undergoing lower extremity surgery under combined spinal epidural anesthesia.
Malondialdehyde
Time frame: 24 hours after surgery
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of malondialdehyde, which is an oxidative stress marker, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
Heme Oxygenase-1
Time frame: 24 hours after surgery
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on the level of heme oxygenase-1, an antioxidant and anti-inflammatory enzyme, in patients who underwent lower extremity surgery under combined spinal epidural anesthesia.
C-Reactive Protein
Time frame: 24 hours after surgery
The primary aim of this study was to investigate the effects of intravenous (iv) administration of dexmedetomidine and ketamine on C-Reactive Protein in patients undergoing lower extremity surgery under combined spinal epidural anesthesia.
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 31 Aug 2023.
- Individual participant dataSharing planned: No. we will decide later.
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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.
İrfan Uç principal investigator
Research Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline, Dexmedetomidine and Ketamine in people with Malondialdehyde and Heme Oxygenase, run by Ataturk University at 1 site in Turkey (Türkiye).
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 10 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 31 Aug 2023. 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 Turkey (Türkiye). 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. 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?
Concentration of Malondialdehyde (time frame: just before surgery). The study lists 9 primary outcomes in all. 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 31 Aug 2023.