Aug 2026· Drug Design, Development and Therapy· Vol 20, pp. 1-16· 1 citation· 52 references
Medicine
TL;DR
Ciprofol was associated with significantly lower PAED scores, indicating reduced EA severity, along with faster emergence, improved recovery quality and higher parental satisfaction compared with propofol, suggesting that ciprofol may be an effective alternative to propofol in pediatric outpatient dental anesthesia.
Abstract
Purpose This prospective randomized controlled trial compared the effects of ciprofol versus propofol on emergence agitation severity, as measured by Pediatric Anesthesia Emergence Delirium (PAED) scores, and on postoperative recovery quality in children undergoing dental procedures under general anesthesia. Patients and Methods This single-center, prospective, double-blind trial enrolled 160 children aged 3–7 years (ASA I–II) scheduled for dental treatment under general anesthesia. Participants were randomized 1:1 to receive ciprofol (n=80) or propofol (n=80). The primary outcome was EA incidence, defined as a Pediatric Anesthesia Emergence Delirium (PAED) score >10 at 5 minutes after awakening. Secondary outcomes included PAED score, extubation and emergence times, postoperative pain (FLACC), respiratory complications, quality of recovery (QoR-15), and parental satisfaction. Results The incidence of EA was 3.8% (3/80) with ciprofol vs 7.5% (6/80) with propofol, with no statistically significant difference between groups (absolute difference: −3.75%; 95% CI: −12.22% to 4.00%; P=0.305). However, ciprofol significantly reduced total PAED scores [median 2.00 (IQR 2.00, 4.00) vs 5.00 (3.00, 7.00); P<0.001], with better scores across all five subscales (all P<0.01). Extubation time (3.83±0.96 vs 5.79±1.42 min; P<0.001) and emergence time (20.90±1.57 vs 22.77±3.28 min; P<0.001) were shorter with ciprofol. QoR-15 scores were higher (129.94±14.95 vs 121.97±16.22; P=0.002), and more parents reported being “very satisfied” (95.0% vs 85.0%; P=0.033) in the ciprofol group. Coughing incidence (5.0% vs 15.0%; P=0.035) and rescue sedation requirements (0.25±1.76 vs 2.33±8.38 mg; P=0.033) were also reduced. No significant difference was observed in FLACC pain scores (P=0.085). Conclusion While the incidence of emergence agitation did not differ significantly between groups, ciprofol was associated with significantly lower PAED scores, indicating reduced EA severity, along with faster emergence, improved recovery quality and higher parental satisfaction compared with propofol. These findings suggest that ciprofol may be an effective alternative to propofol in pediatric outpatient dental anesthesia, though the lack of a statistically significant difference in the primary outcome warrants cautious interpretation.
We read with interest the randomized controlled trial comparing ciprofol with propofol for general anesthesia in children undergoing dental surgery. 1 The study provides useful clinical data on emergence agitation (EA) and postoperative recovery in this population. We would like to comment on several aspects of the outcome assessment and interpretation. First, the timing of PAED assessment should be clarified. EA was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale 5 minutes after awakening. However, the meaning of “awakening” is not clearly defined in relation to the other recovery endpoints. Deep anesthesia extubation was performed in the study, while emergence time was defined as the interval from discontinuation of anesthesia to the child being able to correctly answer simple questions. The PAED scale evaluates several behavioral features of emergence, including eye contact, purposeful actions, awareness of surroundings, restlessness, and inconsolability, so the child’s level of consciousness at the time of assessment is relevant to interpretation of the score. 2 It would therefore be helpful to clarify whether “awakening” referred to eye opening, purposeful interaction, response to verbal commands, or the predefined emergence criterion. It would also be useful to specify whether the PAED assessment was performed 5 minutes after extubation, 5 minutes after reaching the emergence criterion, or at another predefined time point. These details are important when interpreting the primary outcome. Second, the timing of QoR-15 assessment should also be clarified. Parent-proxy assessment of the QoR-15 has previously been used by the authors in younger children undergoing outpatient dental surgery under general anesthesia, with the questionnaire completed 24 hours after surgery. 3 In the present study, however, the QoR-15 was completed by guardians before discharge. Because discharge timing may vary between patients, assessment before discharge could result in different postoperative assessment
Qiu-Cheng Zhao· Drug Design, Development and...· 0 citations
Background Emergence agitation is a clinically relevant phenomenon during recovery from general anesthesia. This study aimed to compare the effects of remimazolam and propofol as anesthetic induction agents on emergence agitation. Methods This retrospective propensity score-matched study included adult patients undergoing elective transurethral endoscopic urologic surgery under general anesthesia. Patients were divided into remimazolam- or propofol-based induction groups. The primary outcome was the incidence of emergence agitation, defined as a Ricker Sedation-Agitation Scale (RSAS) score ≥ 5 during emergence. Secondary outcomes included the severity of emergence agitation, extubation time, postoperative pain scores, use of analgesics or antiemetics in the post-anesthesia care unit (PACU) and risk factor identification. Results A total of 239 patients were analyzed before matching, and 99 matched pairs were generated. After matching, the incidence of emergence agitation was significantly lower in the remimazolam group compared with the propofol group (13.1% vs. 36.4%; P = 0.001). Remimazolam-based induction was independently associated with a reduced risk of emergence agitation (odds ratio 0.23, 95% confidence interval 0.09-0.56; P < 0.001). The distribution of RSAS scores demonstrated reduced severity of agitation in the remimazolam group. Extubation time, postoperative pain scores, and PACU medication did not differ between groups. Younger age and male sex were identified as independent risk factors. Conclusions Remimazolam-based anesthetic induction reduced incidence and severity of emergence agitation compared with propofol, without delaying extubation or impairing early postoperative recovery. Remimazolam may represent a favorable induction agent for adult patients at risk for emergence agitation.
Ji-Yoon Jung, Hwang-Ju You, Woojin Kwon et al.· International Journal of Med...· 0 citations
Purpose Ciprofol provides more stable induction, though its impact on patients’ quality of recovery (QoR) and brain oxygenation requires clarification. This trial assessed whether propofol anesthesia is non-inferior to ciprofol regarding postoperative recovery quality, while additionally comparing their effects on intraoperative cerebral oxygenation. Patients and Methods This single-center, randomized, double-blind, non-inferiority study involved 94 patients scheduled for elective surgery, randomized equally to receive ciprofol (Group C) or propofol (Group P). The primary outcome was the global QoR-15 score measured 24 hours after surgery, with a non-inferiority threshold set at −6.0. Secondary outcomes included 48-hour QoR-15 scores, injection pain frequency, vasopressor requirements, and regional cerebral oxygen saturation (rScO2). Results Eighty- eight patients completed the study (Group C: 44; Group P: 44). In ITT analysis, the mean QoR-15 score at 24 hours for Group C was non-inferior to Group P (Pnon-inferiority < 0.001), with consistent findings in the PP analysis. Similar non-inferiority was observed at 48 hours. However, Group C experienced a notably lower rate of injection pain (4.5% vs 59.0%, P < 0.001) and required less phenylephrine (P = 0.009). Although Group P had higher heart rates after induction of anesthesia (P < 0.05), its average arterial pressure was notably reduced (P < 0.05). Notably, rScO2 in group C was higher than that in group P after induction of anesthesia (P = 0.046) and during the anesthesia maintenance phase (P < 0.05). Conclusion Ciprofol is non-inferior to propofol regarding early postoperative recovery quality. Furthermore, ciprofol mitigates injection pain, reduces vasoconstrictor requirements, and better maintains cerebral oxygenation.
Lideng Guo, Lianjie Cai, Botong Ni et al.· Drug Design, Development and...· 0 citations
BACKGROUND
Post-extubation emergence agitation (EA) is common in pediatric ear, nose, and throat (ENT) procedures and may lead to serious complications.
AIMS
To assess the efficacy of low-dose propofol administered before extubation, compared with placebo, for preventing EA, using meta-analysis with trial sequential analysis (TSA).
METHODS
We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials for randomized controlled trials (RCTs) comparing low-dose propofol versus placebo administered before extubation in pediatric ENT procedures. The primary outcomes were laryngospasm, severity of EA, assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale score, and incidence of EA. Secondary outcomes included post-anesthesia care unit (PACU) length of stay, time to recovery, and time to extubation. Random-effects models were used to pool effect estimates with 95% confidence intervals (CIs). TSA was performed for all outcomes to assess the robustness of the evidence.
RESULTS
Ten RCTs were included in the review, of which six (414 pediatric patients) contributed to the meta-analysis. Compared with control, propofol significantly reduced the incidence of EA (risk ratio [RR] = 0.57; 95% CI, 0.42-0.78) and lowered agitation severity (mean difference [MD] = -3.94; 95% CI, -5.74 to -2.13). Time to extubation was slightly longer (MD = 1.8 min; 95% CI, 1.4-2.3), whereas time to recovery (MD = 0.9 min; 95% CI, -1.9 to 3.6) and PACU length of stay (MD = -0.63 min; 95% CI, -3.2 to 1.9) did not differ. TSA confirmed the robustness of the findings for incidence of EA, severity of EA, and time to extubation. However, the certainty of evidence was very low for severity of EA and moderate for EA incidence and time to extubation. Laryngospasm outcomes were not pooled due to substantial heterogeneity.
CONCLUSIONS
Our findings suggest that pre-extubation propofol probably reduces the incidence of EA in pediatric ENT surgery, supported by moderate-certainty evidence, and may lower EA severity measured by PAED scale scores, for which the certainty of evidence was very low. Propofol was also associated with a slightly longer time to extubation, with no difference in overall recovery time or PACU length of stay.
Rafaela Silva, Raphaela G. Mendes, João Mário M.F. Borges et al.· Paediatric anaesthesia· 0 citations
BACKGROUND
In pediatric anesthesia, minimum alveolar concentration (MAC) guides inhalational agent dosing but may not accurately reflect anesthetic depth. EEG-guided anesthesia has shown benefits in adults but remains underused in children.
AIMS
This study aims to evaluate the effect of EEG-guided anesthesia with SedLine on emergence delirium (ED) and sevoflurane dose in behaviorally noncompliant children undergoing dental procedures under general anesthesia.
METHODS
In this prospective, randomized controlled trial, 100 children aged 4-10 years were randomized to standard anesthesia guided by MAC and conventional clinical signs (standard group) or EEG-guided anesthesia titrated to SedLine parameters (primary target: PSI 25-50; secondary parameter: SEF 10-15 Hz) (EEG-S group). Primary outcome was ED incidence assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAEDS). Secondary outcomes included mean EtSevo values, postoperative pain, rescue analgesia, nausea/vomiting, recovery time.
RESULTS
Median PAEDS scores during the first 120 min postoperatively were significantly lower in the EEG-S group compared with the Standard group (e.g., upon arrival to PACU: 4 [IQR 4] vs. 8 [IQR 4.5]). In addition, the incidence of ED upon arrival in the recovery room was significantly lower in the EEG-S group (17% vs. 43%) and at 10 min postoperatively (17% vs. 37%). The mean end-tidal sevoflurane concentration was statistically lower in the EEG-S group (maintenance EtSevo 1.88 ± 0.25 vs. 1.98 ± 0.20; mean difference = 0.10, 95% confidence interval: 0.006-0.190; p = 0.036). Postoperative FLACC pain scores were also lower in the EEG-S group, representing a potential confounding factor for ED outcomes.
CONCLUSION
EEG-guided anesthesia was associated with lower PAEDS scores and reduced sevoflurane consumption compared with standard management. However, given small EEG-derived differences and potential confounding by postoperative pain, these findings should be interpreted cautiously. Within the applied target ranges, EEG-derived parameters were not independently associated with ED, and specific EEG targets predictive of ED could not be identified.
TRIAL REGISTRATION
This study was registered (Protocol Registration Receipt NCT06400706/OKocaturk/May 02 2024) at http://www.
CLINICALTRIAL
gov.
Ozlem Kocaturk, S. Keles· Paediatric anaesthesia· 0 citations
Purpose To compare ciprofol with propofol for titrated induction of anesthesia in older adults undergoing non-cardiac surgery, with a focus on post-intubation hypotension and related hemodynamic burden. Methods In this prospective, randomized, double-blind trial, adults aged 65–89 years undergoing elective non-cardiac surgery were randomly assigned in a 1:1 ratio to receive either ciprofol or propofol, following an identical titration-to-effect induction protocol. The primary outcome was post-intubation hypotension, defined as any mean arterial pressure (MAP) ≤ 65 mmHg during the 15-minute period after successful tracheal intubation and before surgical incision. Secondary outcomes included hypotension burden expressed as area under the curve (AUC), norepinephrine requirement, cardiac output trajectories, time to loss of consciousness, and early postoperative recovery outcomes. Results 160 patients were randomized. Post-intubation hypotension occurred less frequently in the ciprofol group than in the propofol group (28/77 [36.3%] vs 53/79 [67.0%]; adjusted odds ratio 0.28, 95% confidence interval [CI] 0.15–0.54; P < 0.001), consistent across BIS-adjusted sensitivity analyses. Ciprofol was also associated with a lower AUC for MAP ≤ 65 mmHg (0.0 [0.0–3.2] vs 2.5 [0.0–14.8] mmHg min; P = 0.047), reduced norepinephrine requirement (0.0 [0.0–10.0] µg vs 10.0 [0.0–20.0] µg; P < 0.001), and milder early cardiac output decline (group-by-time interaction β = −0.008, 95% CI −0.010 to −0.005; P < 0.001). No significant between-group differences were observed in early postoperative adverse outcomes. Conclusion In this single-center trial of older adults undergoing non-cardiac surgery, ciprofol-based titrated induction was associated with less post-intubation hypotension, lower rescue vasopressor requirement, and less cumulative hypotensive exposure than propofol, without an apparent increase in early adverse recovery outcomes. These findings suggest a favorable hemodynamic profile of ciprofol, which requires confirmation in larger multicenter studies.
Hong Bai, Jing Guo, Yu-Mei Li et al.· Clinical Interventions in Ag...· 0 citations