Emergence agitation (EA) is a transient, self-limited, non-fluctuating state of psychomotor excitement, which closely revolves around the emergence of general anesthesia. Uncontrolled EA during the recovery period increases the potential risk of injury to patients and medical staff, resulting in varying degrees of adverse consequences, such as elevated blood pressure, incision rupture, bleeding, cardio-cerebrovascular accidents and so on, leading to a great waste of resources. Accumulating scientific evidence indicates that the incidence of EA is related to the use of perioperative sedative drugs. As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether perioperative sedation of Remimazolam besylate, propofol, and sevoflurane have different effects on the incidence of emergence agitation and hemodynamics in patients undergoing laparoscopic abdominal surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,317
Anesthesia was induced with Rematazolam Besylate 0.3\~0.5 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS\<60, followed by remimazolam 1-3 mg/kg/h until the end of surgery.
Anesthesia was induced with Propofol 2\~2.5 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS\<60, followed by remimazolam 5\~12 mg/kg/h until the end of surgery.
Anesthesia was induced with etomidate 0.03 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS\<60, followed by 2 %-3 % Sevoflorane until the end of surgery.
Anesthesia was induced with Sufentanil 0.3\~0.5 ug/kg by intravenous injection after the LoC and BIS\<60.
Anesthesia was induced with cisatracurium besilate 0.2-0.3 mg/kg by intravenous injection after the LoC and BIS\<60, followed by 0.1 mg/kg/h Cisatracurium Besylate during the operation.
After the LoC, remifentanil 0.1\~0.3 ug/kg/min inject intravenously until the end of surgery.
People's Hospital of Ganzhou
Ganzhou, Jiangxi, China
the First Affiliated Hospital of Gannan Medical College, Gannan Medical College
Ganzhou, Jiangxi, China
The First People's Hospital of JiuJiang
Jiujiang, Jiangxi, China
the Second Affiliated Hospital of Nanchang University, Nanchang University
Nanchang, Jiangxi, China
Tumor Hospital of Jiangxi Province
Nanchang, Jiangxi, China
Shangrao People's Hospital
Shangrao, Jiangxi, China
The incidence of emergence agitation
The Riker Sedation-Agitation Scale (RSAS) score ≥ 5 points indicates the presence of emergence agitation.
Time frame: Duration from the time patients awakening to the time of departure from post-anesthesia care unit (PACU), average 1 hour.
The incidence of emergence agitation
The Richmond Agitation-Sedation Scale (RASS) ≥ +1 points indicates the presence of emergence agitation.
Time frame: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Systolic pressure
Time frame: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Diastolic pressure
Time frame: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Mean pressure
Time frame: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Heart rate
Time frame: "30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Recovery times
Recovery times is defined as the period from discontinuation of anesthetic drugs to the recovery of the patient's self-consciousness and can respond correctly to external stimuli.
Time frame: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Delayed emergence
Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.
Time frame: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
The incidence of postoperative delirium
The incidence of postoperative delirium was assessed using CAM Scale.
Time frame: Record in the mornings on the 1st, 3rd and 7th day after operation.
Postoperative Pain
The Numericrating scale (NRS) is grouped from 0 to 10. The degree of pain increased directly with the score.
Time frame: Record in the mornings on the 1st, 3rd and 7th day after operation.
Complication
All the perioperative complications are recorded.
Time frame: During the perioperative period, up to 1 week.
Hospitalization time
The length of hospital stay is recorded.
Time frame: After the patient is discharged from the hospital, average 1 week.
Hospital expenses
Hospitalization costs include total hospitalization costs and anesthesia costs.
Time frame: After the patient is discharged from the hospital, average 1 week.
30-day all-cause mortality
30-day all-cause mortality is recorded.
Time frame: 30 days after surgery
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