Comparison of the Effects of Three Different Anesthetic Methods on Postoperative Agitation in Septoplasty Surgery
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Inonu University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Emergence agitation
Overview
Brief Summary
Adult patients undergoing septoplasty surgery will be evaluated in this study. The three different anesthesia methods used will be examined for psotoperative agitation: Total intravenous anesthesia (TIVA), Combined anesthesia with sevoflurane and intravenous agents (sevoflurane-CIVIA), Balanced inhalation anesthesia with sevoflurane. Recovery patterns is extubation time, eye opening time, emergence agitation, postoperative nausea and vomiting and postoperative recovery unit discharge time.
Detailed Description
Agitation, defined as restlessness, disorientation, arousal, and/or inconsolable crying, is a common phenomenon seen in the early phase of recovery from general anesthesia. It can lead to respiratory depression, nausea, and vomiting, as well as increases in blood pressure, heart rate, and myocardial oxygen consumption. Hypoxia can lead to serious complications such as aspiration pneumonia, bleeding, or reoperation. Although its pathogenesis remains unclear, ear, nose, and throat (ENT) surgical procedures have been reported to have a higher incidence of agitation in both adults and children.
Classic general anesthesia is performed with induction using an intravenous hypnotic such as propofol and maintenance with a volatile anesthetic such as sevoflurane, along with intermittent or continuous opioids and muscle relaxants. Opinions differ regarding the effects of inhalational and intravenous anesthesia on maintenance. A 2015 retrospective study investigating the risk factors for emergence agitation after rhinoplasty reported that sevoflurane use more than doubled the risk of emergence agitation.
The use of propofol and sevoflurane for maintenance has recently been recommended due to the antiemetic effects of propofol, the myocardial protective effects of sevoflurane, and the potential for smoother emergence from the administration of small amounts of each anesthetic . This study aimed to compare the occurrence of emergence agitation after inhalation anesthesia, total intravenous anesthesia with TCI, and combined inhalation and intravenous anesthesia in patients undergoing septoplasty surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Double (Participant, Care Provider)
Masking Description
Participant: The participant will be unaware of which anesthesia method is performed in the perioperative period.
Care Provider: The second anesthesiologist will wake the patient after the anesthesia has been terminated and will not know which anesthesia method was used.
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 50 years old.
- •American Society of Anesthesiologists (ASA) Physical Status Class I or II.
- •Scheduled for elective septoplasty surgery.
- •Scheduled to receive general anesthesia
Exclusion Criteria
- •History of revision septoplasty
- •Known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) or the study drugs
- •History of bleeding disorder
- •History of allergy
- •ASA Physical Status greater than III
- •Body Mass Index (BMI) $\> 30
- •History of hypertension, cardiovascular diseases, or cerebrovascular diseases
- •History of renal dysfunction
- •Use of psychiatric medications
- •History of substance abuse
Arms & Interventions
Group T (TIVA)
After entering the patient's demographic data (height, gender, weight, and age), the Eleveld model (MedCaptain Eleveld HP TCI Infusion Syringe Pump) will be set to Ce 4 µg/mL for propofol and Ce 4 ng/mL for remifentanil in the Minto model. Ventilation with a face mask will be performed using 100% O2 after loss of consciousness and disappearance of the eyelash reflex. When the BIS value drops below 60, measurement of the degree of neuromuscular blockade (TOF - watch TOFWatch SX, Organon, Ireland) will be initiated. Rocuronium will be administered as a bolus at a dose of 0.6 mg/kg according to ideal body weight, and intubation will be performed. Anesthesia will be maintained by increasing or decreasing the target concentration of propofol by 0.5 μg/mL to keep the BIS value in the 40-60 range. The target remifentanil concentration will be increased or decreased by 0.5 ng/mL to maintain mean arterial pressure at 60-70 mmHg.
Intervention: TIVA (Drug)
Group C (CIVIA)
After entering the patient's demographic data (height, gender, weight, and age), the Ce level will be set to 4 µg/mL for propofol in the Eleveld model and 4 ng/mL for remifentanil in the Minto model. Ventilation will be performed with a face mask using 100% O2 after loss of consciousness and disappearance of the eyelash reflex. When the BIS value drops below 60, measurement of the degree of neuromuscular blockade will be initiated. Rocuronium will be administered as a bolus at a dose of 0.6 mg/kg according to ideal body weight, and intubation will be performed. For maintenance of anesthesia, inhaled sevoflurane concentration will be started at 0.5 MAC, while the propofol Ce level will be adjusted to 2 µg/mL, and propofol will be increased or decreased by 0.5 μg/mL to maintain the BIS target in the 40-60 range. Remifentanil infusion will be administered to maintain mean arterial pressure at 60-70 mmHg, with a titration of 0.5 ng/mL.
Intervention: CIVIA (Drug)
Group S (Sevoflurane)
After entering the patient's demographic data (height, gender, weight, and age), the initial target concentration (Ce) at the site of action for propofol will be recorded as 4 µg/mL in the Eleveld model (MedCaptain Eleveld HP TCI Infusion Syringe Pump), and the target concentration (Ce) for remifentanil will be recorded as 4 ng/mL in the Minto model. Ventilation will be performed with a face mask using 100% O2 after loss of consciousness and disappearance of the eyelash reflex. When the BIS value drops below 60, measurement of the degree of neuromuscular blockade (TOFWatch S monitor; Organon, Dublin, Ireland) will be initiated. Rocuronium will be administered as a bolus at a dose of 0.6 mg/kg according to ideal body weight, followed by intubation. Anesthesia maintenance will be provided with sevoflurane to keep the BIS value between 40-60. The target remifentanil concentration will be increased or decreased by 0.5 ng/mL to maintain mean arterial pressure (MAP) at 60-70 mmHg.
Intervention: SEVOFLURANE (Drug)
Outcomes
Primary Outcomes
Emergence agitation
Time Frame: Immediately after tracheal extubation
Emergence agitation will be assessed using the Richmond Agitation-Sedation Scale (RASS). RASS is a 10-point scale ranging from +4 to -5, measures agitation, sedation level, and responsiveness.
Secondary Outcomes
- Postoperative nausea and vomiting (PONV)(Immediately post-op, 15 minutes, and 30 minutes in the Post-Anesthesia Care Unit (PACU))
- Extubation time(Immediately postoperative period)
- Recovery time(Continuous observation for 30 minutes in the PACU.)
Investigators
Ülkü Özgül
Prof.Dr.
Inonu University