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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05640427
Enrollment
105
Registered
2022-12-07
Start date
2022-03-22
Completion date
2023-03-22
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Dexmedetomidine, Anxiety

Brief summary

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

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.

Interventions

DRUGDexmedetomidine

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.

DRUGnormal saline

The same capacity of 0.9% normal saline was used in group C

Sponsors

The First Hospital of Qinhuangdao
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of anxiety at one day after surgeryOne day after surgeryThe 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.
Incidence of anxiety at three days after surgeryThree days after surgeryThe 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.

Secondary

MeasureTime frameDescription
Anesthetic drugTime Frame: during the surgeryThe dosage of remifentanil and propofol in different groups were recorded.
The change of SBPbefore anesthesia induction, at the time of intubation, at the beginning of surgery, immediately after surgery , and five minutes after extubationThe change of Systolic blood pressure (SBP) among the three groups.
The change of rScO2during the surgeryThe change of regional cerebral oxygen saturation(rScO2) among the three groups.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026