Amobarbital Sodium, Hemodynamics Instability
Conditions
Keywords
Anesthesia induction, Perioperative Adverse Reactions, Gynecological Laparoscopic Surgery
Brief summary
At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery. The main questions it aims to answer are: * whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients; * whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction. Participants will: * Induction of anesthesia with the experimental drug or placebo； * 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels； * To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded.
Interventions
DRUGAmobarbital
Participants with gynecological laparoscopic surgery who met the trial inclusion criteria were randomly divided into 2 groups. After entering the room, peripheral intravenous infusion was opened and oxygen was absorbed by the mask for 5 L/min. Mean arterial pressure, heart rate and oxygen saturation were routinely monitored. After positioning, the amobarbital-propofol group was given amobarbital sodium 1 mg/kg 1 min before induction, followed by Sufentanil 0.5ug /kg, cisatracurium 0.2mg /kg, penehyclidine hydrochloride 0.01mg /kg, propofol 1.5mg /kg for general anesthesia induction. The propofol group was given the same volume of normal saline 1 min before anesthesia induction, followed by Sufentanil 0.5ug /kg, cisatracurium 0.2mg /kg, penehyclidine hydrochloride 0.01mg /kg, propofol 2.5mg /kg.
DRUGPropofol
propofol
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 40\ 60 years old； * ASA Class I to II； * The operation time was 1h\ 2h； * BMI 18\ 25； * Sign informed consent.
Exclusion criteria
* Known allergy to narcotic drugs used in this study; * Severe pulmonary insufficiency; * Abnormal liver and kidney function； * History of severe anemia and hematoporphyrin； * History of asthma; * Uncontrolled high blood pressure or diabetes; * Pregnant and lactating women； * Accompanied by cognitive impairment or inability to communicate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial pressure (MAP) during Induction of anesthesia | Up to 3 hours | MAP was recorded as the main index of hemodynamics during anesthesia induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MAP at different time points | Up to 3 hours | MAP at different time points (including before induction, tracheal intubation, cutting the skin, extubation) |
| Incidence of postoperative nausea and vomiting (ponv) | 24 hours | The incidence of perioperative adverse reactions (ponv) was recorded |
Outcome results
None listed