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

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

Detailed Description
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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.

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

Conditions
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Anxiety

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group C<br>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. | Drug: normal saline<br>* The same capacity of 0.9% normal saline was used in group C<br>|
| Experimental: Group D1<br>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. | Drug: Dexmedetomidine<br>* Groups D1 received general anesthesia with intravenous pump of 0. 2μg/kg/h dexmedetomidine to 30min before the end of the operation.Groups D2 received general anesthesia with intravenous pump of 0. 5μg/kg/h dexmedetomidine to 30min before the end of the operation.<br>|
| Experimental: Group D2<br>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. | Drug: Dexmedetomidine<br>* Groups D1 received general anesthesia with intravenous pump of 0. 2μg/kg/h dexmedetomidine to 30min before the end of the operation.Groups D2 received general anesthesia with intravenous pump of 0. 5μg/kg/h dexmedetomidine to 30min before the end of the operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of anxiety at one day after surgery | The three groups of patients were scored on the Self-rating Anxiety Scale on the first day after surgery, and if the Self-rating Anxiety Scale score was ≥ 50 points, the patients developed anxiety, and whether the incidence of anxiety on the first day after surgery in the three groups was statistically significant. | One day after surgery | 
| Incidence of anxiety at three days after surgery | The three groups of patients were scored on the Self-rating Anxiety Scale on the third day after surgery, and if the Self-rating Anxiety Scale score was ≥ 50 points, the patients developed anxiety, and whether the incidence of anxiety on the third day after surgery in the three groups was statistically significant. | Three days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic drug | The dosage of remifentanil and propofol in different groups were recorded. | Time Frame: during the surgery | 
| The change of SBP | The change of Systolic blood pressure (SBP) among the three groups. | before anesthesia induction, at the time of intubation, at the beginning of surgery, immediately after surgery , and five minutes after extubation | 
| The change of rScO2 | The change of regional cerebral oxygen saturation(rScO2) among the three groups. | during the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Dexmedetomidine