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Effects of different doses of Remazolam toluenesulfonic acid on sedation and hemodynamics in elderly patients undergoing painless colonoscopy: a randomized controlled trial.

Effects of different doses of Remazolam toluenesulfonic acid on sedation and hemodynamics in elderly patients undergoing painless colonoscopy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034549
Enrollment
Unknown
Registered
2020-07-09
Start date
2020-06-30
Completion date
Unknown
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painless colonoscopy

Interventions

Group A:Low dose (0.1mg/kg) rumazolam toluene sulfonate
Group B:Medium dose (0.12mg/kg) rumazolam toluene sulfonate
Group C:High dose (0.14mg/kg) Rumazolam toluene sulfonate

Sponsors

The First People's Hospital of Shuangliu District, Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) A person older than 60 years of age who plans to undergo diagnostic or therapeutic colonoscopy (treatment procedures may include hemostasis, resection, ablation, decompression, removal of foreign bodies, etc.); (2) the American society of anesthesiologists (ASA) classification: ? ~ level III; (3) BMI <= 40kg /m2; (4) Sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Known allergy to benzodiazepines, flumazine, opioids, and naloxone; (2) long-term use of benzodiazepines and opioids; (3) opioids and alcohol abuse; (4) Previous history of neuropsychiatric illness; (5) received any study drug within 30 days prior to screening or less than 7 half-lives (whichever is older) or was likely to receive any related drug during study follow-up; (6) severe heart, lung, liver, and renal dysfunction (MET 2, basic SpO2 < 92%, abnormal biochemical indicators of liver and kidney function); (7) Audio-visual and communication barriers exist.

Design outcomes

Primary

MeasureTime frame
Effective sedation rate;

Secondary

MeasureTime frame
onset time;awakening time;HR;MAP;SpO2;Time out of the operating room;MMSE score before and after examination;

Countries

China

Contacts

Public ContactSun Ting-ting

The First People's Hospital of Shuangliu District, Chengdu

20946285@qq.com+86 13882073250

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026