Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00552617
Other study ID # P05971
Secondary ID 19.4.208BMK-8616
Status Completed
Phase Phase 2
First received
Last updated
Start date September 20, 2005
Est. completion date August 31, 2006

Study information

Verified date November 2019
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) during sevoflurane anesthesia for Caucasian participants.


Description:

For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Sugammadex has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium induced neuromuscular blockade. The current trial P05971 was conducted in Europe and set up to establish the dose response relationship of sugammadex given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Caucasian participants. In addition to recovery time, also pharmacokinetics and safety of sugammadex were to be evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 31, 2006
Est. primary completion date August 31, 2006
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- Is of American Society of Anesthesiologists (ASA) class 1 - 3;

- Is at least 20 years but under 65 years of age;

- Caucasian participants;

- Is scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia with an anticipated duration of about 1.5-3 hours;

- Has given written informed consent.

Exclusion criteria:

- Participants in whom a difficult intubation because of anatomical malformations was expected;

- Is known or suspected to have neuromuscular disorders impairing neuromuscular blocking (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.

- Is known or suspected to have a (family) history of malignant hyperthermia;

- Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;

- Is receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;

- Females who were pregnant;

- Females of childbearing potential not using birth control or using only oral contraception as birth control;

- Was breast-feeding;

- Has already participated in P05971, or in another trial with sugammadex;

- Has participated in another clinical trial, not preapproved by the Sponsor, within 6 months of entering into P05971.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sugammadex
After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered
Placebo
After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of Placebo IV was administered
Rocuronium
After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary.
Vecuronium
After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV. Maintenance doses of 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Pühringer FK, Gordon M, Demeyer I, Sparr HJ, Ingimarsson J, Klarin B, van Duijnhoven W, Heeringa M. Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship. Br — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time From Start of Administration of Sugammadex or Placebo to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB. Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.9 (up to 24 hours)
Secondary Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.7 Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB. Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (up to 24 hours)
Secondary Time From Start of Administration of Sugammadex or Placebo to Recovery of the T4/T1 Ratio to 0.8 Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB. Day 1: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (up to 24 hours)
See also
  Status Clinical Trial Phase
Recruiting NCT06063798 - Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery N/A
Not yet recruiting NCT05035069 - Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR Phase 4
Completed NCT03861364 - Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose. Phase 4
Completed NCT02711280 - The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children N/A
Completed NCT01199471 - Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane N/A
Completed NCT00917033 - Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy Phase 4
Completed NCT00391885 - Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy Phase 4
Completed NCT03705026 - Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting in Chinese Han Population
Completed NCT00552929 - A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974) Phase 2
Completed NCT00475215 - Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017) Phase 3
Completed NCT00298831 - Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023) Phase 3
Recruiting NCT03943745 - EEG Changes During Induction of Propofol Anesthesia
Completed NCT03697642 - Nasopharyngeal Airway Guide Nasogastric Tube Placement N/A
Completed NCT04595591 - Observation of Propofol Titration at Different Speeds N/A
Not yet recruiting NCT05841316 - The ED95 Dose of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
Completed NCT04532502 - Impact of Anesthetic Environment the Sex Ratio of the Children of Female Assistants
Completed NCT03330236 - EEG - Guided Anesthetic Care and Postoperative Delirium N/A
Recruiting NCT06205212 - High-flow Nasal Oxygenation During Preoxygenation and Atelectasis N/A
Completed NCT00379613 - Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942) Phase 2
Completed NCT03841890 - The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure N/A