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

NCT05640427 | Completed

• 1 other identifier: 2022ZH0218
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety

Keywords

Dexmedetomidine; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Anesthetic drug

  Time Frame: during the surgery

• The change of SBP

  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

  during the surgery

Study Arms (3)

Group C

PLACEBO COMPARATOR

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

Group D1

EXPERIMENTAL

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

Group D2

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

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.

Group D1; Group D2

normal saline DRUG

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

Group C

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Qinhuangdao: lead

Study Sites (1)

The First hosptial of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shujuan Liang, Master

  The First hosptial of Qinhuangdao

  STUDY DIRECTOR

• Hua Zhou, Master

  The First hosptial of Qinhuangdao

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 7, 2022
• Study Start: March 22, 2022
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: August 23, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)