Hypotension, Hypertension
Conditions
Keywords
Oliceridine, Sufentanil, Anesthesia Induction, Gynecological Laparoscopic Surgery, Hemodynamic, Older Adults
Brief summary
Blood pressure can fall during the start of general anesthesia, particularly in older patients with high blood pressure. This study compared two medicines, oliceridine and sufentanil, to assess their effects on low blood pressure during anesthesia induction in older women with hypertension undergoing gynecological laparoscopic surgery. This single-center randomized controlled trial enrolled 134 women aged 65 to 80 years at the Affiliated Hospital of Nantong University. Participants were assigned to receive either oliceridine or sufentanil, together with the same other anesthesia induction medicines. Blood pressure and heart rate were measured before induction, one minute after induction, immediately after insertion of the breathing tube, and one and five minutes after insertion. The main outcome was the proportion of participants who experienced low blood pressure during these measurements. Low blood pressure was defined as a mean arterial pressure below 65 mmHg or a decrease of at least 30% from the value measured before induction. Other assessments included changes and variability in blood pressure, heart rate, and the use of medicines to support blood pressure.
Interventions
DRUGOliceridine
Intravenous oliceridine 0.10 mg/kg administered during anesthesia induction.
DRUGSufentanil
Intravenous sufentanil 0.50 micrograms/kg administered during anesthesia induction.
Sponsors
Xingguo Xu
Affiliated Hospital of Nantong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants and personnel collecting data and assessing outcomes were unaware of treatment allocation. The anesthesiologists administering the study medications were aware of allocation. Surgical staff were unaware of allocation.
Intervention model description
This single-center randomized controlled trial assigned 134 participants in a 1:1 ratio to receive either oliceridine or sufentanil during anesthesia induction, with 67 participants in each group.
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female participants aged 65 to 80 years. * Body mass index of 18.5 to 30.0 kg/m². * American Society of Anesthesiologists (ASA) physical status classification II or III. * Scheduled for elective gynecological laparoscopic surgery under general anesthesia. * Diagnosed with hypertension before surgery. * Provided written informed consent to participate.
Exclusion criteria
* Allergy to the study medications or contraindications to their use. * Psychiatric or cognitive impairment preventing cooperation with study procedures. * History of chronic pain, long-term heavy alcohol consumption, or opioid misuse. * Use of analgesic or sedative medications within 48 hours before surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hypotension During Anesthesia Induction | From one minute after anesthesia induction through five minutes after tracheal intubation. | Percentage of participants with hypotension at any of the four assessment time points: one minute after anesthesia induction, immediately after tracheal intubation, and one and five minutes after intubation. Hypotension is defined as mean arterial pressure (MAP) below 65 mmHg or a decrease of at least 30% from the pre-induction baseline MAP. Participants meeting either criterion at one or more assessment time points are counted once. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Mean Arterial Pressure | From one minute after anesthesia induction through five minutes after tracheal intubation | Lowest mean arterial pressure (MAP), in mmHg, among measurements obtained one minute after anesthesia induction, immediately after tracheal intubation, and one and five minutes after intubation. |
| Maximum Percentage Decrease in Mean Arterial Pressure | From one minute after anesthesia induction through five minutes after tracheal intubation. | Maximum percentage decrease in mean arterial pressure (MAP) from the pre-induction baseline across the four post-induction assessment time points. Percentage decrease is calculated as 100 × (baseline MAP - post-induction MAP) / baseline MAP. |
| Change in Mean Arterial Pressure From Baseline | Baseline before induction; one minute after induction; immediately after intubation; one and five minutes after intubation. | Change in mean arterial pressure (MAP), in mmHg, from the pre-induction baseline at each assessment time point. Change is calculated as MAP at the assessment time point minus baseline MAP; negative values indicate a decrease. |
| Mean Arterial Pressure at Specified Time Points | Baseline before induction through five minutes after tracheal intubation. | Mean arterial pressure (MAP), in mmHg, measured before anesthesia induction, one minute after induction, immediately after tracheal intubation, and one and five minutes after intubation. |
| Heart Rate at Specified Time Points | Baseline before induction through five minutes after tracheal intubation. | Heart rate, in beats per minute, measured before anesthesia induction, one minute after induction, immediately after tracheal intubation, and one and five minutes after intubation. |
| Percentage of Participants Receiving Vasoactive Medication | From initiation of anesthesia induction through five minutes after tracheal intubation. | Percentage of participants receiving at least one vasoactive medication to support blood pressure during the anesthesia induction observation period. Each participant is counted once regardless of the number of doses administered. |
Countries
China
Outcome results
None listed