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Completed

NCT Number: NCT05294679

Explore the Clinical Application Value of Ciprofol in Painless Colonoscopy

This study used propofol as a positive control, and adopted a large-sample, multi-center, randomized, double-blind, positive parallel controlled trial design to explore the clinical application value of ciprofol in painless colonoscopy.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mengchang Yang

Chengdu, Sichuan, 610000, China

About this study

Subjects were randomly assigned 1:1 to receive intravenous ciprofol or propofol 1 hour prior to diagnosis and treatment. A centralized random grouping method was used in this study. After screening subjects, the researchers in each test center will log in to the random system after being confirmed by the researchers of the center, fill in the screening information, obtain the random number information, and issue the corresponding study drugs according to the random number. Random shelter number was generated by SAS software, and was used as the total blind base pair drug number and imported into the centralized random grouping system. In this study, evaluation researchers and drug administration researchers were set up. The whole process of the experiment was blind not only to the subjects, but also to the evaluation researchers. Evaluation investigators and administration investigators were set up in this study. The administration investigators were only involved in the process of random grouping, drug dispensing and administration, and the other processes including informed consent of subjects, screening, evaluation of efficacy indicators and safety, and planned visits were all completed by the evaluation investigators.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing painless colonoscopy;
  • Patients aged from 18 to 80 years old, no gender limitation; 3, 18 < BMI < 30kg/m2 [BMI = weight (kg)/ height (m) squared]
  • American Society of Anesthesiologists (ASA) grades ⅰ ~ ⅲ

Exclusion criteria

  • Preoperative blood pressure >160/100 mmHG or < 80/50 mmHG.
  • Preoperative ecg suggested heart rate <50 times/min;
  • Acute respiratory tract infection with no cured history within 2 weeks;
  • People with serious metabolic diseases such as heart, brain, lung, liver, kidney and diabetes;
  • Predict people who may have or have had difficult airway;
  • Patients with obvious electrolyte disorders such as hyperkalemia;
  • Long-term use of immunosuppressants such as hormones or history of adrenocortical inhibition;
  • People who are known to be allergic to emulsions and opioids;
  • Preoperative combined use of other sedative and analgesic drugs
  • Suspected abuse of narcotic analgesics or sedatives; 11, there are neuromuscular system diseases, mental diseases and other people do not cooperate with the communication;

Treatment and study plan

Propofol

Drug

All patients completed pre-anaesthesia assessment, signed informed consent, and completed vital signs on the day before surgery, with values as baseline vital signs. On the day of surgery, after routine preparation before colonoscopy (fasting for at least 6h and water restriction for at least 2h before surgery), venous access was established in the left hand. 0.5μg/kg fentanyl was administered intravenously after oxygen inhalation through a nasal catheter (4-6 L/min). About 3 minutes after fentanyl administration, sedation induction was performed with ciprofol or propofol immediately.

ciprofol

Drug

Ciprofol

Primary outcomes

  1. the incidence of hypotension

    Time frame: Day 1

    Perioperative hypotension was defined as systolic blood pressure below 90mmHg, diastolic blood pressure below 50mmHg, or systolic blood pressure below baseline

Secondary outcomes

  1. the successful sedation time

    Time frame: Day 1

    When the Patients'MOAA/S was 0 as the successful sedation time

  2. Blood pressure

    Time frame: Day 1

    Record the blood pressure at entering the room (T0) , after anesthesia administration (T1),at time points 2min after anesthesia administration (T2), 4min after anesthesia administration (T3), at the end of surgery (T4), 5min after surgery (T5), 10min after surgery (T6), and before leaving the chamber (T7)

  3. Heart rate

    Time frame: Day 1

    Record the heart rate at entering the room (T0) , after anesthesia administration (T1),at time points 2min after anesthesia administration (T2), 4min after anesthesia administration (T3), at the end of surgery (T4), 5min after surgery (T5), 10min after surgery (T6), and before leaving the chamber (T7)

  4. Respiratory rate

    Time frame: Day 1

    Record the respiratory rate at entering the room (T0) , after anesthesia administration (T1),at time points 2min after anesthesia administration (T2), 4min after anesthesia administration (T3), at the end of surgery (T4), 5min after surgery (T5), 10min after surgery (T6), and before leaving the chamber (T7)

  5. Oxygen saturation(SpO2 %)

    Time frame: Day 1

    Record the oxygen satuaition at entering the room (T0) , after anesthesia administration (T1),at time points 2min after anesthesia administration (T2), 4min after anesthesia administration (T3), at the end of surgery (T4), 5min after surgery (T5), 10min after surgery (T6), and before leaving the chamber (T7)

  6. Steward wakefulness Score

    Time frame: Day 1

    Minimum value =0, maximum value =6, the higher the score, the higher the degree of wakefulness

  7. Directional force score

    Time frame: Day 1

    Minimum value =0, maximum value =10, the higher the score, the higher the degree of directivity

  8. Incidence of adverse events

    Time frame: Day 1

    including injection pain, intraoperative muscle fibrillation, hypoxemia, body movement, and postoperative complications

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

Clinical Use of Ciprofol in Painless Colonoscopy: a Large Sample, Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 24, 2022
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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