Elderly Patients
Conditions
Keywords
fospropofol, propofol, sedation, elderly, bidirectional endoscopy
Brief summary
Introduction: Fospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties compared with propofol. This trial aims to compare the efficacy and safety of fospropofol versus propofol sedation for same-day bidirectional endoscopy in elderly patients. Methods and analysis: This is a prospective, single-center, double-blind, randomized, propofol-controlled, non-inferiority trial. A total of 256 adult patients scheduled for same-day bidirectional endoscopy under sedation will be randomly allocated, in a 1:1 ratio, to a fospropofol group or a propofol group (n=128 in each group). All patients will receive analgesic pretreatment with sufentanil 5 μg. Two minutes later, an initial bolus dose of fospropofol 6.5 mg/kg or 1.5 mg/kg propofol and supplemental doses of fospropofol 1.6 mg/kg or 0.5 mg/kg propofol will be titrated as needed to the target sedation levels during the procedures. The primary outcome is the success rate of same-day bidirectional endoscopy. Secondary outcomes include the time to successful induction of sedation, duration, time to being fully alert, time to patient discharge, endoscopist satisfaction, patient satisfaction, and the top-up frequency and dosage of sedative medications. The safety endpoints consist of adverse events (AEs) concerning cough reflex, gag reflexes, body movement, muscular tremor, pain on injection. Sedation-related AEs, including episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia, will be also recorded. Data will be analyzed on the intention-to-treat basis. Discussion: The investigators hypothesize that the efficacy and safety of fospropofol sedation for elderly patients undergoing same-visit bidirectional endoscopy will not be inferior to that of propofol. The findings will provide daily practice of sedation regimens for same-day bidirectional endoscopy in elderly patients.
Interventions
DRUGfospropofol sedation
Fospropofol sedation for same-day bidirectional endoscopy in elderly patients
DRUGPropofol
propofol
Sponsors
Shanghai 6th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 65 years or older * American Society of Anesthesiologists (ASA) physical status I to III * Body mass index (BMI) 18-30 kg/m2 * Scheduled for same-day bidirectional endoscopy under sedation
Exclusion criteria
* Severe cardiovascular, pulmonary, renal, or liver diseases * Previous hypotension (systolic blood pressure ≤90 mmHg), bradycardia (heart rate \<50 beats/min), or hypoxemia (SpO2 \<90%) * Neurocognitive or psychiatric disorders * Contraindications to gastroscopy (gastric retention, long-term aspirin administration, etc.) * Hypersensitivity to study medications * Drug or alcohol misuse * Definite upper respiratory tract infection * Refusal for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The success rate of same-day bidirectional endoscopy | Immediate time after sedation emergence | The success rate of the gastrointestinal endoscopy was assessed according to the following criteria : 1) completion of the gastrointestinal endoscopy; 2) no need for rescue sedative/anesthetic, which means the top-up doses of the experimental drugs were administered no more than five times within any 15-min window from the initial administration to the end of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time to successful induction of sedation | Immediate time after sedation emergence | the time counted from the start of drug administration to the achievement of a sedation score (MOAA/S ) ≤ 1 |
| Time to being fully alert | Immediate time after sedation emergence | the time from gastrointestinal endoscopy extraction or/and the time from the last drug administration to a MOAA/S score of 5 on three consecutive measurements; |
| Time to patient discharge | Immediate time of hospital discharge | Time to patient discharge |
| Endoscopist's satisfaction questionnaire | Immediate time after sedation procedure completion | Endoscopist's satisfaction |
| Patient's satisfaction questionnaire | Immediate time of hospital discharge | Patient's satisfaction |
| The top-up frequency and dosage of sedative medications | Immediate time after sedation emergence | The top-up frequency and dosage of sedative medications |
| Incidence of adverse events (AEs) at timepoint 2 | Intraoperative (during sedation) | Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. |
| Incidence of adverse events (AEs) at timepoint 3 | Intraoperative (the timepoint of sedation emergence) | Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. |
| Incidence of adverse events (AEs) at timepoint 4 | 15 min in post-anesthesia care unit | Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. |
| Incidence of adverse events (AEs) at timepoint 5 | 30 min in post-anesthesia care unit | Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. |
| Incidence of adverse events (AEs) at timepoint 6 | Immediate time of hospital discharge | Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. |
| Incidence of adverse events (AEs) at timepoint 1 | baseline (Prior to sedation) | Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia. |
Outcome results
None listed