THE EFFECT OF CHRONIC SSRI/SNRI ANTIDEPRESSANT TREATMENT ON PROPOFOL CONSUMPTION IN ELECTIVE SPINE SURGERY: A PROSPECTIVE COHORT STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Total Intraoperative Propofol Consumption
研究概览
简要总结
THE GOAL OF THIS OBSERVATIONAL STUDY IS TO LEARN WHETHER LONG-TERM USE OF SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRI) OR SEROTONIN-NOREPINEPHRINE REUPTAKE INHIBITOR (SNRI) ANTIDEPRESSANTS IS RELATED TO THE AMOUNT OF PROPOFOL NEEDED DURING PLANNED SPINE SURGERY. PROPOFOL IS A MEDICINE GIVEN THROUGH A VEIN TO PRODUCE AND MAINTAIN ANESTHESIA.
THE MAIN QUESTIONS THIS STUDY AIMS TO ANSWER ARE:
- DO PATIENTS WHO REGULARLY TAKE AN SSRI OR SNRI NEED A DIFFERENT TOTAL AMOUNT OF PROPOFOL DURING SURGERY THAN PATIENTS WHO DO NOT TAKE THESE MEDICINES?
- ARE THERE DIFFERENCES IN PROPOFOL AND REMIFENTANIL USE, DEPTH OF ANESTHESIA, VITAL SIGNS, OR RECOVERY TIME BETWEEN THE STUDY GROUPS?
THE STUDY WILL INCLUDE 216 ADULTS UNDERGOING PLANNED SPINE SURGERY. RESEARCHERS WILL COMPARE 108 PARTICIPANTS WHO REGULARLY TAKE AN SSRI OR SNRI WITH 108 PARTICIPANTS WHO DO NOT TAKE THESE MEDICINES.
ALL PARTICIPANTS WILL RECEIVE ROUTINE ANESTHESIA CARE. THE STUDY WILL NOT START, STOP, OR CHANGE ANY ANTIDEPRESSANT TREATMENT, AND PARTICIPANTS WILL NOT BE RANDOMLY ASSIGNED TO A GROUP. RESEARCHERS WILL RECORD THE AMOUNT OF PROPOFOL AND REMIFENTANIL USED DURING SURGERY, BLOOD PRESSURE, HEART RATE, OXYGEN LEVEL, DEPTH OF ANESTHESIA, AND RECOVERY TIME.
详细描述
SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) AND SEROTONIN-NOREPINEPHRINE REUPTAKE INHIBITORS (SNRIS) ARE CONSIDERED FIRST-LINE PHARMACOLOGICAL AGENTS IN THE TREATMENT OF DEPRESSION AND ANXIETY DISORDERS (1). THESE DRUGS SELECTIVELY INCREASE SEROTONIN CONCENTRATIONS IN THE SYNAPTIC CLEFT BY INHIBITING THE SEROTONIN TRANSPORTER (SERT); THEY SUPPRESS NOREPINEPHRINE AND DOPAMINE REUPTAKE ONLY MINIMALLY (1). HOWEVER, SSRI AND SNRI AGENTS HAVE THE POTENTIAL TO CAUSE HYPERTENSIVE EFFECTS (2). THE HYPERTENSIVE MECHANISM IS ASSOCIATED WITH SSRIS RAISING SYNAPTIC SEROTONIN LEVELS THROUGH SERT INHIBITION, RESULTING IN OVERSTIMULATION OF 5-HT1A AND 5-HT2A RECEPTORS (3). SEROTONIN EXCESS ACTIVATES THE SYMPATHETIC NERVOUS SYSTEM, TRIGGERING VASOCONSTRICTION, TACHYCARDIA, AND CATECHOLAMINE RELEASE, LEADING TO AN INCREASE IN BLOOD PRESSURE; THIS INDIRECTLY INCREASES THE NEED FOR INTRAOPERATIVE ANESTHETIC (4). ADDITIONALLY, SSRIS-ESPECIALLY POTENT CYP2D6 INHIBITORS SUCH AS PAROXETINE AND FLUOXETINE-CAN REDUCE THE ANALGESIC EFFECTS OF PRODRUG-TYPE OPIOIDS (E.G., CODEINE, HYDROCODONE, AND TRAMADOL) BY INHIBITING THEIR METABOLISM (5). THIS INTERACTION BLOCKS THE CONVERSION OF PRODRUGS TO ACTIVE METABOLITES (CODEINE → MORPHINE; HYDROCODONE → HYDROMORPHONE) VIA THE CYP2D6 ENZYME IN THE LIVER, REDUCING PLASMA ACTIVE OPIOID CONCENTRATIONS AND DISRUPTING Μ-OPIOID RECEPTOR ACTIVATION; ULTIMATELY LEADING TO A HIGHER OPIOID DOSE REQUIREMENT FOR PATIENTS (5). AS A PARALLEL MECHANISM, SEROTONIN EXCESS (AT HIGH DOSES OR IN INTERACTION WITH OTHER AGENTS) CAN INDUCE SEROTONIN-INDUCED HYPERALGESIA; THIS PROCESS OCCURS THROUGH STIMULATION OF THE CAMP SECONDARY MESSENGER SYSTEM VIA 5-HT1A RECEPTORS IN PERIPHERAL NERVE ENDINGS AND POTENTIATES THE TENDENCY TOWARDS HYPERALGESIA (6). CONSIDERING THESE DESCRIBED MECHANISMS, MAINTAINING A CONSTANT REMIFENTANIL DOSE DURING THE INTRAOPERATIVE PERIOD MAY INCREASE PROPOFOL CONSUMPTION (7). HOWEVER, DESPITE THIS THEORETICAL INFORMATION, THE EFFECT OF SSRI-SNRI USE ON PROPOFOL CONSUMPTION DURING THE PERIOPERATIVE PERIOD HAS NOT BEEN SUFFICIENTLY INVESTIGATED. THEREFORE, THIS STUDY WILL INVESTIGATE THE RELATIONSHIP BETWEEN THESE TWO FACTORS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Study period: Between October 2026 and April 2027,
- •Study location: Kocaeli City Hospital Operating Rooms,
- •Type of surgery: Patients scheduled for spinal surgery,
- •Medication use: Patients using chronic SSRI or SNRI group antidepressants in the preoperative period, but not using antipsychotics or other group antidepressants (e.g., TCA, MAOI, atypical antidepressants),
- •Age criterion: Adult individuals aged 18 and over,
- •ASA classification: Patients in ASA 2-3 group,
排除标准
- •1. Patients who cannot give informed consent and individuals under 18 years of age,
- •Patients with an ASA (American Society of Anesthesiologists) physical status classification of ASA IV or higher,
- •Cases requiring emergency surgical intervention,
- •Patients undergoing surgery due to trauma,
- •Patients using antidepressants other than selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs),
- •Cases maintained with inhalation anesthesia.
研究组 & 干预措施
Chronic SSRI/SNRI Treatment Group
Participants receiving chronic selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) therapy before elective spine surgery. These medications will not be initiated, discontinued, or modified for study purposes. Intraoperative propofol consumption and prespecified perioperative outcomes will be recorded.
Control Group
Adults undergoing elective spine surgery who are not receiving chronic SSRI or SNRI therapy and are not using antipsychotic or other antidepressant medications. Participants will receive routine BIS-guided total intravenous anesthesia with propofol and remifentanil. No study-specific intervention will be administered. Perioperative variables and total anesthetic drug consumption will be recorded.
结局指标
主要结局
Total Intraoperative Propofol Consumption
时间窗: From induction of anesthesia until the end of surgery, on the day of surgery
The total cumulative dose of propofol administered during anesthetic induction and BIS-guided total intravenous anesthesia maintenance will be recorded in milligrams (mg) for each participant. Total propofol consumption will be compared between participants receiving chronic SSRI/SNRI therapy and control participants.
次要结局
- Total Intraoperative Remifentanil Consumption(From induction of anesthesia until the end of surgery, on the day of surgery)
- Difference in Total Intraoperative Propofol Consumption Between the SSRI and SNRI Groups(From induction of anesthesia to the end of surgery)