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Completed

NCT Number: NCT07838948

Nalbuphine With Remimazolam Versus Nalbuphine With Propofol for Knee Arthroscopy

This study compared two combinations of medicines used for sedation and pain relief in adults undergoing knee arthroscopy for knee joint injuries. One group received nalbuphine with remimazolam, and the other received nalbuphine with propofol. The study examined pain, sedation, cognitive function, and adverse events. A total of 100 adults aged 18 to 65 years were randomly assigned to the two groups, with 50 participants in each group. All participants underwent surgery under combined spinal-epidural anesthesia. Pain, sedation, and cognitive function were assessed immediately after surgery and at 6, 12, and 24 hours after surgery.

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Key information

Conditions

Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wuhan Fourth Hospital

Wuhan, Hubei, 430035, China

About this study

This single-center, randomized, parallel-group study was conducted at Wuhan Fourth Hospital. Participants were assigned using a random-number table. Both groups were managed by the same anesthesia team. Intraoperative assessments included blood pressure, heart rate, respiratory rate, oxygen saturation, anesthesia induction time, anesthesia duration, and awakening time. Postoperative assessments included the Visual Analog Scale for pain, the Ramsay Sedation Scale, and the Mini-Mental State Examination. Adverse events assessed included hypotension, respiratory depression, bradycardia, postoperative agitation, nausea and vomiting, pruritus, chills, and diplopia. The study was approved by the Wuhan Fourth Hospital ethics committee, and participants provided written informed consent before surgery.

No primary outcome measure was prespecified before the study began. This registration is being prepared after study completion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Knee joint injury diagnosed by clinical and imaging examinations, with planned knee arthroscopy.
  • Age 18 to 65 years.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Normal preoperative cognitive function, with Mini-Mental State Examination (MMSE) score >=24.
  • No long-term preoperative use of analgesic, sedative, or antipsychotic medication.

Exclusion criteria

  • Psychiatric disorders, including depression, anxiety, or schizophrenia, or neurological disorders, including Parkinson disease, epilepsy, or post-stroke sequelae.
  • Allergy to nalbuphine, remimazolam, or related medications.
  • Severe hepatic or renal impairment, including cirrhosis or chronic renal failure, or uncontrolled hypertension or diabetes mellitus.
  • Considered unsuitable for participation by the investigators.
  • Serious intraoperative complications, including anesthesia accidents or massive intraoperative bleeding, or withdrawal during the study (post-enrollment exclusion or withdrawal criteria).

Treatment and study plan

Nalbuphine

Drug

Nalbuphine 0.1 mg/kg was administered intravenously at induction in both study groups.

Remimazolam

Drug

Remimazolam 0.2-0.3 mg/kg was administered intravenously at induction in the experimental group. If body movement occurred during the procedure, an additional intravenous dose of 0.05 mg/kg was administered as needed until completion.

Propofol

Drug

Propofol 1.5-2.0 mg/kg was administered intravenously at induction in the active comparator group. If body movement occurred during the procedure, an additional intravenous dose of 0.5 mg/kg was administered as needed until completion.

Primary outcomes

  1. Postoperative pain measured by the Visual Analog Scale (retrospectively designated)

    Time frame: Immediately after surgery and at 6, 12, and 24 hours after surgery

    Postoperative pain intensity assessed using a Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (severe pain). Lower scores indicate less pain. Scores are compared between the two treatment groups at each specified assessment. No primary outcome was prespecified before the study began. This measure is designated as primary for this retrospective registration after study completion; it was not a prospectively specified primary endpoint.

Secondary outcomes

  1. Postoperative sedation measured by the Ramsay Sedation Scale

    Time frame: Immediately after surgery and at 6, 12, and 24 hours after surgery

    Sedation assessed with the Ramsay Sedation Scale, ranging from 1 to 6. Higher scores indicate deeper sedation. Scores are compared between the treatment groups at each assessment. Outcome classification is assigned for this retrospective registration; no primary outcome hierarchy was prespecified before study initiation.

  2. Postoperative Mini-Mental State Examination score

    Time frame: Immediately after surgery and at 6, 12, and 24 hours after surgery

    Cognitive performance assessed using the Mini-Mental State Examination (MMSE), with scores ranging from 0 to 30. Higher scores indicate better performance. Scores are compared between the treatment groups at each assessment. Outcome classification is assigned for this retrospective registration; no primary outcome hierarchy was prespecified before study initiation.

  3. Incidence of postoperative agitation

    Time frame: From the end of surgery through 24 hours after surgery

    Percentage of participants with postoperative agitation recorded during postoperative observation. The manuscript does not specify a grading scale or severity threshold. Classification as a secondary outcome is assigned for retrospective registration.

  4. Incidence of postoperative nausea and vomiting

    Time frame: From the end of surgery through 24 hours after surgery

    Percentage of participants with postoperative nausea and vomiting recorded during postoperative observation. Classification as a secondary outcome is assigned for retrospective registration.

  5. Incidence of intraoperative hypotension

    Time frame: During surgery

    Percentage of participants with systolic blood pressure below 90 mmHg or a decrease greater than 20% from baseline during surgery. Classification as a secondary outcome is assigned for retrospective registration.

  6. Incidence of intraoperative respiratory depression

    Time frame: During surgery

    Percentage of participants with oxygen saturation below 90% or respiratory rate below 8 breaths per minute during surgery. Classification as a secondary outcome is assigned for retrospective registration.

  7. Incidence of bradycardia

    Time frame: During the perioperative observation period, through 24 hours after surgery

    Percentage of participants with heart rate below 50 beats per minute. Classification as a secondary outcome is assigned for retrospective registration.

  8. Incidence of pruritus, chills, and diplopia

    Time frame: During the perioperative observation period, through 24 hours after surgery

    The percentage of participants experiencing each of the following events is assessed separately: pruritus, chills, and diplopia. This is not a composite endpoint. Classification as a secondary outcome is assigned for retrospective registration.

  9. Intraoperative blood pressure

    Time frame: During surgery

    Systolic, diastolic, and mean arterial pressure measured in mmHg during surgery are compared separately between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.

  10. Intraoperative heart rate

    Time frame: During surgery

    Heart rate measured in beats per minute during surgery and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.

  11. Intraoperative respiratory rate

    Time frame: During surgery

    Respiratory rate measured in breaths per minute during surgery and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.

  12. Intraoperative oxygen saturation

    Time frame: During surgery

    Peripheral oxygen saturation (SpO2), expressed as a percentage, recorded during surgery and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.

  13. Anesthesia induction time

    Time frame: During anesthesia induction on the day of surgery

    Time required for anesthesia induction, recorded in minutes and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.

  14. Duration of anesthesia

    Time frame: During anesthesia on the day of surgery

    Duration of anesthesia, recorded in minutes and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.

  15. Awakening time

    Time frame: During recovery from anesthesia on the day of surgery

    Time to awakening after anesthesia, recorded in minutes and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.

  16. Postoperative cognitive impairment based on the manuscript MMSE threshold

    Time frame: Immediately after surgery and at 6, 12, and 24 hours after surgery

    Percentage of participants with a Mini-Mental State Examination score of 24 or less, the threshold described in the manuscript as suggesting cognitive dysfunction. MMSE scores range from 0 to 30, with higher scores indicating better performance. Classification as a secondary outcome is assigned for retrospective registration.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Wuhan Fourth Hospital

Unknown

Registry information

Official study title

Investigating the Effect of Subanesthetic Doses of Nalbuphine Combined With Remimazolam in Patients Undergoing Arthroscopic Knee Surgery for Knee Joint Injuries

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

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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