丙泊酚/盐酸氯胺酮(Propofol/Ketamine Hydrochloride) - 药物靶点：GABAA receptor x NMDA receptor_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Ketofol

靶点

GABAA receptor x NMDA receptor

作用方式

激动剂

作用机制

GABAA receptor激动剂(γ-氨基丁酸 A 受体激动剂)、NMDA receptor激动剂(谷氨酸[NMDA]受体复合体激动剂)

治疗领域-

在研适应症-

非在研适应症-

原研机构-

在研机构-

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C12H18O

InChIKeyOLBCVFGFOZPWHH-UHFFFAOYSA-N

CAS号2078-54-8

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关联

160

项与丙泊酚/盐酸氯胺酮相关的临床试验

NCT07627906

/ Recruiting临床3期IIT

Neuroprotective Effects of Ketofol Versus Ketodex on Postoperative Delirium in Elderly Patients Undergoing Pelvi-abdominal Cancer Surgeries. A Randomized Double-blinded Comparative Study.

Postoperative delirium (POD) is a common and serious neurocognitive complication after surgery, particularly in elderly patients undergoing major cancer surgeries. It is associated with prolonged hospital stay, impaired quality of life, increased postoperative cognitive dysfunction, and higher mortality. The pathophysiology of POD is multifactorial and involves neuroinflammation, oxidative stress, impaired cerebral perfusion, and neurotransmitter imbalance.
Several anesthetic agents have been investigated for their potential neuroprotective effects against POD. Ketamine, through NMDA receptor antagonism, may reduce neuroinflammation and provide hemodynamic stability and opioid-sparing analgesia, although concerns remain regarding hallucinations and psychomimetic effects. Propofol, acting through GABA receptor activation, may protect against oxidative neuronal injury but may also induce hypotension in elderly patients. Dexmedetomidine, a selective α2-adrenergic agonist, has shown promising sedative, analgesic, and anti-inflammatory properties with potential protective effects against POD, although bradycardia and uncertainty regarding optimal dosing remain concerns.
Combinations such as ketofol (ketamine-propofol) and ketodex (ketamine-dexmedetomidine) may provide synergistic benefits by improving hemodynamic stability, analgesia, and sedation while minimizing adverse effects. Previous studies have demonstrated favorable perioperative outcomes with both combinations; however, direct comparisons regarding their role in preventing postoperative delirium in elderly patients undergoing pelvi-abdominal cancer surgeries remain limited. Therefore, this study aims to compare the efficacy and safety of ketofol versus ketodex as prophylactic strategies against POD in this high-risk population.

开始日期2026-07-01

申办/合作机构

Cairo University

NCT07530146

/ Recruiting临床3期IIT

Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation

The study is a prospective randomized controlled trial comparing the efficacy and safety of propofol-ketamine ("Ketofol") versus propofol monotherapy in geriatric ICU patients. Eligible participants are critically ill elderly patients with a history of cardiac disease who require endotracheal intubation and have not yet received sedation. The investigators focus on a specific population in which geriatric patients have different pharmacokinetics and pharmacodynamics and are more prone to side effects than other populations.
Primary outcome: Incidence of hemodynamic instability (defined as hypotension requiring vasopressors), measured by mean arterial pressure (MAP) at baseline, during intubation, and post-intubation at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours.

开始日期2026-04-01

申办/合作机构

Helwan University

NCT07401914

/ Active, not recruitingN/AIIT

The Effect of Anesthesia Protocols Used in Gastrointestinal Endoscopy Procedures in Adolescents on the Outcome

Gastrointestinal endoscopic procedures in adolescents require effective sedoanalgesia to ensure procedural comfort and prevent agitation. Pain control is an essential component of these procedures, and current practice commonly involves low-dose combinations of anesthetic agents. Sedoanalgesia protocols are selected according to patient characteristics and the anesthesiologist's clinical experience. This prospective observational study aims to compare the effects of ketodex and ketofol on intraoperative procedural comfort, postoperative recovery, and patient satisfaction in adolescents undergoing gastrointestinal endoscopy.

开始日期2026-02-02

申办/合作机构

Giresun University

100 项与丙泊酚/盐酸氯胺酮相关的临床结果

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100 项与丙泊酚/盐酸氯胺酮相关的转化医学

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100 项与丙泊酚/盐酸氯胺酮相关的专利（医药）

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147

项与丙泊酚/盐酸氯胺酮相关的文献（医药）

2026-09-01·JOURNAL OF CLINICAL NEUROSCIENCE

Effect of dexmedetomidine as an adjuvant in erector spinae plane block on postoperative analgesia in thoracolumbar spine surgery with an opioid free anaesthesia technique: A prospective randomized clinical trial

Article

作者: Reddy, Ashwini ; Bhatia, Nidhi ; Mahajan, Shalvi ; Kumar, Vishal ; Verma, Swati ; Gandhi, Komal ; Kaloria, Narender ; Chauhan, Rajeev ; Panda, Nidhi Bidyut

BACKGROUND:

Spine surgery is associated with intense postoperative pain, necessitating effective analgesia for optimal postoperative outcome. This study aimed to evaluate the analgesic efficacy of dexmedetomidine as an adjuvant in ultrasound guided erector spinae plane block (ESPB) in patients undergoing thoracolumbar spine surgery using opioid-free anaesthesia (OFA). The postoperative pain free period was primary outcome, and pain scores, 24-hour rescue analgesic requirements, qNOX values for intraoperative analgesia, perioperative hemodynamics and overall patient satisfaction score were secondary outcomes.

METHODOLOGY:

This prospective double-blind randomized trial enrolled 40 patients aged 18--65 years undergoing T8-L3 spine surgery. The patients were randomly allocated to the following groups: Group RD [0.2% ropivacaine (0.5 ml/kg) and dexmedetomidine (1 µg/kg)] and Group R [0.2% ropivacaine (0.5 ml/kg) only]. Following onset of ESPB block, patients were given general anaesthesia using Ketofol infusion (1 ml Ketofol contains 8.33 mg of Propofol + 1.67 mg of Ketamine) under qCON and qNOX monitoring.

RESULTS:

Group RD demonstrated statistically significant extended pain-free period (15 vs 8.3 h, P = 0.001) and reduced pain scores at 4th, 6th, and 8th hours compared to Group R (P = 0.015, 0.001, 0.001 respectively). Lower 24-hour second-line rescue analgesic needs (P = 0.001) and increased patient satisfaction (P = 0.001) were observed in Group RD compared to Group R. However, intraoperative hemodynamics and analgesia were comparable in both the groups (p > 0.05).

CONCLUSION:

The addition of dexmedetomidine with ESPB was associated with improved postoperative analgesia, reduced requirement for second-line rescue analgesia and increased patient satisfaction following thoraco-lumbar spine surgery with OFA using Ketofol.

2026-04-01·BMJ Open

Incidence and associated factors of inadequate emergence in elderly patients undergoing elective major abdominal surgery: a prospective cohort study in Northwest Ethiopia

Article

作者: Yetneberk, Tikuneh ; Zegeye, Sitotaw Tesfa ; Aligaz, Esubalew Muluneh ; Fetene, Melaku Bantie ; Endeshaw, Amanuel Sisay ; Amberbir, Wubet Dessie ; Bayable, Samuel Debas ; Debas, Simachew Amogne ; Ale, Yewlsew Fentie

Background:

Inadequate emergence is a common postoperative complication in elderly patients following major abdominal surgery. This study was designed to determine its incidence, identify associated risk factors and characterise its clinical subtypes within this high-risk cohort.

Design and setting:

This prospective single-centre cohort study was conducted at a comprehensive specialised tertiary care hospital in Northwest Ethiopia. Consecutive patients aged 65 years and older scheduled for elective major abdominal surgery under general anaesthesia were enrolled.

Primary outcome measure:

The primary outcome was the proportion of patients experiencing inadequate emergence.

Results:

A total of 388 patients were analysed. Inadequate emergence occurred in 21.9% of participants (95% CI 14.3% to 31.6%), with hypoactive emergence observed in 10.7% and emergence delirium in 11.2%. Multivariable logistic regression identified several independent predictors, including advanced age (adjusted OR (AOR)=1.9; 95% CI 1.5 to 8.2), preoperative anxiety (AOR=2.7; 95% CI 1.2 to 7.2), prolonged preoperative fasting (AOR=2.1; 95% CI 1.8 to 9.1), non-ketofol-based induction (AOR=3.4; 95% CI 1.6 to 6.3), absence of abdominal field block (AOR=4.2; 95% CI 4.0 to 9.6), substantial intraoperative blood loss (>1000 mL; AOR=1.9; 95% CI 1.2 to 7.6), postoperative nausea and vomiting requiring antiemetics (AOR=2.2; 95% CI 2.1 to 7.1) and presence of an indwelling urinary catheter (AOR=2.4; 95% CI 1.8 to 7.9).

Conclusions:

Inadequate emergence occurred in approximately one in five elderly patients undergoing elective major abdominal surgery. Independent predictors included advanced age, major intraoperative blood loss, postoperative nausea/vomiting requiring antiemetics, non-ketofol-based induction, preoperative anxiety, absence of abdominal field block, presence of an indwelling urinary catheter and prolonged preoperative fasting.

2026-02-01·JOURNAL OF CLINICAL ANESTHESIA

Randomized clinical trial between two sedation protocols during transcatheter aortic valve replacement procedures: Ketamine and Propofol versus Remifentanil and Dexmedetomidine

Article

作者: Gomarasca, Mattia ; Calzolari, Alessandro ; Mistraletti, Giovanni ; Castiglioni, Claudia ; Lucchelli, Matteo ; Moro Salihovic, Bedrana ; Orsenigo, Francesca ; Salice, Valentina ; Castellari, Anna ; Mondin, Federico

OBJECTIVES:

To compare efficacy and safety of two different sedation protocols during Transcatheter Aortic Valve Replacement (TAVR); Ketamine and Propofol (KETOFOL) versus Remifentanil and Dexmedetomidine (REMIDEX).

DESIGN:

Monocentric, prospective, randomized and controlled trial.

SETTING:

University hospital.

PARTICIPANTS:

231 patients were enrolled in the trial. 198 patients were included in the final analysis.

INTERVENTIONS:

Patients enrolled underwent procedural sedation according to one of the two possible drug combinations, KETOFOL vs REMIDEX, assigned through randomization. During the procedure intervention times and clinical parameters were recorded. After the procedure incidence of postoperative adverse events were recorded.

MEASUREMENTS AND MAIN RESULTS:

REMIDEX group showed a higher trend in the raw incidence of respiratory acidosis (67.7 % vs 54.3 %). The correlation was confirmed in the multivariate logistic regression analysis, with an increased risk of developing respiratory acidosis in the REMIDEX group (OR 1.864 %, 95 % CI 1.014-3.427). Patients in the REMIDEX group showed significantly longer induction times. REMIDEX group required a greater number of pharmacological adjustments, had a higher incidence of intraoperative agitation, and more episodes of desaturation. No other differences were observed in any of the other intraoperative or postoperative safety indicators.

CONCLUSIONS:

Both protocols showed a low and comparable incidence of cardiovascular adverse events and postoperative complications such as POD and POCD. KETOFOL protocol appears to offer greater sedative stability and seems to be more protective regarding the incidence of respiratory adverse events.

100 项与丙泊酚/盐酸氯胺酮相关的药物交易

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研发状态

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02863861 (Pubmed \| Braz J Anesthesiol)	临床4期	镇静	120	Propofol-Ketamine	蓋蓋選鹽繭壓襯範鏇醖(鹽夢廠構鏇艱網鬱範繭) = 簾鏇艱鑰窪網獵廠淵獵艱遞廠糧積遞餘糧齋選 (觸衊醖遞顧蓋襯網壓鹹 ) 更多	-	2020-11-01
				Dexmedetomidine-Ketamine	蓋蓋選鹽繭壓襯範鏇醖(鹽夢廠構鏇艱網鬱範繭) = 鑰窪窪鹽鬱構壓廠蓋遞艱遞廠糧積遞餘糧齋選 (觸衊醖遞顧蓋襯網壓鹹 ) 更多
NCT02643979 (CTgov)	临床4期	睡眠呼吸暂停综合征 \| 肥胖	22	propofol+Saline (Propofol Only)	襯窪憲願鑰願獵網鑰範 = 網積衊壓淵遞鬱構蓋淵遞蓋築衊獵壓遞積獵艱 (壓夢鏇構繭鹽壓鑰糧夢, 選廠簾鹹繭獵獵選鏇鹹 ~ 構艱製網糧鬱壓構網構) 更多	-	2020-01-28
				Ketofol+propofol (Ketofol and Propofol)	製積壓襯窪衊廠築齋鬱(繭醖願簾鬱膚選獵網鹽) = 壓淵築鏇顧選蓋壓憲鹽簾鹽醖齋壓繭選鏇憲膚 (醖獵艱簾獵範糧鬱襯觸, 壓製廠簾鏇鏇衊鹹鹽範 ~ 製鏇蓋製構醖網廠淵艱) 更多
NCT02105415 (KEEP PACE \| KEEP PACE Trial, CTgov)	临床2/3期	危重病	160	Etomidate (Etomidate)	繭醖觸鏇襯築鹽襯觸獵(選餘鹽鹹廠製製廠繭餘) = 鏇遞窪廠積壓鏇選醖願鏇壓積網艱鹽廠構構獵 (網蓋構鏇糧鹽鹹齋醖糧, 17.9) 更多	-	2019-01-11
				Ketamine / Propofol Admixture (Ketamine / Propofol Admixture)	繭醖觸鏇襯築鹽襯觸獵(選餘鹽鹹廠製製廠繭餘) = 選鹹膚遞鬱遞獵鏇簾鬱鏇壓積網艱鹽廠構構獵 (網蓋構鏇糧鹽鹹齋醖糧, 13.3) 更多
NCT02848963 (Pubmed \| J Anesth)	临床4期	-	75	1:5 ketofol mixture	獵顧鑰積願糧鏇廠醖構(積餘蓋鬱構繭網窪遞繭) = 鹹鏇壓艱蓋窪選願積築廠鑰網鑰獵鏇醖壓鑰餘 (衊獵廠鬱廠願築鬱糧獵, 308.1 ~ 434.48) 更多	-	2018-02-01
				1:6.7 ketofol mixture	獵顧鑰積願糧鏇廠醖構(積餘蓋鬱構繭網窪遞繭) = 築膚網夢鹹鏇糧築蓋淵廠鑰網鑰獵鏇醖壓鑰餘 (衊獵廠鬱廠願築鬱糧獵, 292.2 ~ 394.3) 更多
ACTRN12610001056088 (POKER Study, Pubmed \| Ann Emerg Med)	N/A	镇静 \| 镇痛	-	Ketofol	鏇蓋願壓築衊繭獵鹽鏇(構遞築獵糧積築膚築選) = 顧鏇獵衊鬱衊窪憲糧糧積糧糧獵餘鏇願製夢獵 (壓鏇蓋簾範餘鹽製築構 ) 更多	-	2016-11-01
				Propofol	鏇蓋願壓築衊繭獵鹽鏇(構遞築獵糧積築膚築選) = 獵網衊鹹窪糧醖築構蓋積糧糧獵餘鏇願製夢獵 (壓鏇蓋簾範餘鹽製築構 ) 更多
NCT01260662 (CTgov)	临床4期	镇静	271	propofol (Propofol)	蓋鏇餘鹹艱蓋鏇夢憲積 = 餘廠膚糧顧顧糧築獵選齋憲積窪醖廠淵糧憲鹽 (願窪獵糧衊製鏇艱齋願, 鹽鑰製築糧夢網蓋夢蓋 ~ 製鏇觸積繭窪遞襯構淵) 更多	-	2015-04-29
				1:1 Propofol/Ketamine (1:1 Propofol/Ketamine)	蓋鏇餘鹹艱蓋鏇夢憲積 = 糧鏇願襯顧遞鬱鑰夢齋齋憲積窪醖廠淵糧憲鹽 (願窪獵糧衊製鏇艱齋願, 願鑰齋鏇範構夢鏇蓋築 ~ 廠壓築繭衊鏇範醖築願) 更多
Pubmed \| Anaesth Intensive Care	临床4期	-	45	Ketofol (0.5 mg/kg propofol plus 0.5 mg/kg ketamine)	範製鬱醖網觸蓋壓壓鬱(壓鹹窪願餘製鹹糧憲獵) = 製網壓繭鑰艱餘衊壓願鹹衊糧鹽積遞鑰壓夢製 (膚觸構鏇廠憲鏇鏇願醖 ) 更多	-	2012-03-01
				Propofol 1%	範製鬱醖網觸蓋壓壓鬱(壓鹹窪願餘製鹹糧憲獵) = 襯膚積膚範淵淵鏇蓋鏇鹹衊糧鹽積遞鑰壓夢製 (膚觸構鏇廠憲鏇鏇願醖 ) 更多
Pubmed \| Acad Emerg Med	临床3期	镇静 \| 镇痛	219	Ketofol	醖淵膚鑰網鹽遞鬱窪鏇(夢膚襯範夢鹹餘壓鏇鏇) = 膚鹹顧憲壓築觸築選觸築窪鹽願壓襯壓淵襯繭 (製網製糧齋網網範構鏇 ) 更多	-	2010-02-01
Pubmed \| Ann Emerg Med	临床3期	镇静	284	Ketofol	夢衊築築願鬱鹽艱餘襯(簾淵築築鏇顧網鑰構蓋) = 4 patients (3.5%; 95% CI 1.0% to 8.7%) required adjunctive medication for sedation 觸艱夢壓繭構鹽構齋積 (膚鬱顧衊鑰襯鬱鏇淵鏇 ) 更多	积极	2007-01-01