Effect of Different Doses of Dexmedetomidine on Cerebral Oxygen Saturation and Postoperative Anxiety in Elderly Patients

The First Hospital of Qinhuangdao

Status: Completed

Conditions: Anxiety

Treatments: Drug: normal saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05640427

2022ZH0218

Details and patient eligibility

About

To investigate the effect of different doses of dexmedetomidine on Cerebral Oxygen Saturation and Postoperative anxiety in elderly patients undergoing laparoscopic surgery

Full description

A total of 105 patients who were admitted to The First Hospital of Qinhuangdao for laparoscopic surgery and divided into control group (group C), dexmedetomidine doses of 0.2 μg/kg (group D1), dexmedetomidine doses of 0.5 μg/kg (group D2).

105 patients were randomized equally into 3 groups. 35 cases in each group. Group C received general anesthesia without dexmedetomidine, groups D1 received general anesthesia with intravenous pump of 0. 2μg/kg/h dexmedetomidine, groups D2 received general anesthesia with intravenous pump of 0. 5μg/kg/h dexmedetomidine.SBP(Systolic Blood Pressure),DP(Diastolic Pressure),HR(Heart Rate) and rScO2(Regional cerebral oxygen saturation) of the three groups were recorded before anesthesia induction (T1), at the time of intubation (T2), five minutes after induction(T3),at the beginning of surgery (T4), immediately after surgery (T5), and five minutes after extubation (T6).

The cognitive function of the three groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of the three groups was assessed with Self-rating Anxiety Scale (SAS) on the day before surgery,one day after and three days after surgery, comparing the incidence of anxiety between the three groups. Analyze whether dexmedetomidine reduced the incidence of anxiety by increasing cerebral oxygen saturation.

Enrollment: 105 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged 65 years or older who underwent elective laparoscopic surgery under general anesthesia
• BMI less than 30 kg/m2
• American Society of Anesthesiologists (ASA) grades I-III
• The score of Mini Mental state examination≥24

Exclusion criteria

• Patients with heart, lung and other vital organ disorders
• The score of Mini Mental state examination≤23
• Preoperative psychiatric disorders or long-term use of drugs affecting the psychiatric system
• Have severe visual, hearing, speech impairment or other inability to communicate with the visitor
• Refuse to sign informed consent
• known preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second-degree or greater atrioventricular block without pacemaker

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups, including a placebo group

Group C

Placebo Comparator group

Description:

Group C received general anesthesia with intravenous normal saline. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.

Treatment:

Drug: normal saline

Group D1

Experimental group

Description:

groups D1 received general anesthesia with intravenous pump of 0. 2μg/kg/h dexmedetomidine. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.

Treatment:

Drug: Dexmedetomidine

Group D2

Experimental group

Description:

groups D2 received general anesthesia with intravenous pump of 0. 5μg/kg/h dexmedetomidine. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.

Treatment:

Drug: Dexmedetomidine