- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05640427
Effect of Different Doses of Dexmedetomidine on Cerebral Oxygen Saturation and Postoperative Anxiety in Elderly Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Hebei
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Qinhuangdao, Hebei, China, 066000
- Recruiting
- The First hosptial of Qinhuangdao
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Group C
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.
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The same capacity of 0.9% normal saline was used in group C
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Experimental: Group D1
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.
|
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.
|
Experimental: Group D2
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of anxiety at one day after surgery
Time Frame: 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.
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One day after surgery
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Incidence of anxiety at three days after surgery
Time Frame: Three days after surgery
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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.
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Three days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anesthetic drug
Time Frame: Time Frame: during the surgery
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The dosage of remifentanil and propofol in different groups were recorded.
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Time Frame: during the surgery
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The change of SBP
Time Frame: before anesthesia induction, at the time of intubation, at the beginning of surgery, immediately after surgery , and five minutes after extubation
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The change of Systolic blood pressure (SBP) among the three groups.
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before anesthesia induction, at the time of intubation, at the beginning of surgery, immediately after surgery , and five minutes after extubation
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The change of rScO2
Time Frame: during the surgery
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The change of regional cerebral oxygen saturation(rScO2) among the three groups.
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during the surgery
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Collaborators and Investigators
Investigators
- Study Director: Shujuan Liang, Master, The First hosptial of Qinhuangdao
- Study Chair: Hua Zhou, Master, The First hosptial of Qinhuangdao
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Anxiety Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- 2022ZH0218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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