Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06242262
Other study ID # 36264PR461/12/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 3, 2024
Est. completion date July 1, 2024

Study information

Verified date February 2024
Source Tanta University
Contact Ahmed M Ibrahim, MD
Phone 00201141779238
Email ahmed.edib@med.tanta.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effect of deep neuromuscular block on postoperative pain, duration of surgery, quality of surgical field, length of recovery room stays, Total amount of rescue analgesic, postoperative nausea/vomiting, and length of hospital stay.


Description:

Acute-pain management in surgery patients is accompanied by an array of negative consequences, including increased morbidity, impaired physical function, and quality of life, slowed recovery, prolonged opioid use during and after hospitalization, and increased cost of care. Reducing pneumo-peritoneum (PP) is one technique for reducing postoperative pain. The effect of low PP on postoperative pain remains a controversial topic with other studies reporting no difference in postoperative pain levels between the Two pressures. Deep neuromuscular block (DNMB) in abdominal surgeries is associated with various advantages, such as lower abdominal pressure, lower pain and rescue opioid consumption, as well as less bleeding. DNMB may facilitate the use of reduced insufflation pressure without compromising the surgical field of vision. However, its usage is limited due to a lack of predictable and rapid recovery with conventional NMB antagonists (neostigmine) or spontaneous recovery


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age 18 to 65 years old. - Both sexes. - American Society of Anesthesiologists (ASA) physical status I-III. - Patients scheduled for laparoscopic abdominal surgery. Exclusion Criteria: - Known allergies to cis-atracurium or neostigmine. - Contraindications to the use of neostigmine, such as bronchial asthma, glaucoma, myocardial ischemia, and epilepsy. - History of neuromuscular, renal, or hepatic disease; previous abdominal surgery. - Treatment with drugs known to affect neuromuscular function. - Preoperative hyperalgesia. - Peripheral neuropathy is caused by diabetes. - History of chronic analgesics treatment, drug, or alcohol abuse. - Body mass index (BMI) > 35 kg/m2.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Deep neuromuscular block
Patients will receive deep neuromuscular block by using cis-atracurium. After tracheal intubation for 15 min, a cis-atracurium pump will be started, and its rate will be adjusted to maintain a post-tetanic count (PTC) in the 1-2 range.
Moderate neuromuscular block
Patients will receive moderate neuromuscular block by using cis-atracurium. Pump delivery of cis-atracurium will be started when the TOF count returned to 2. The TOF count is maintained between 1 and 3 by adjusting the pump rate

Locations

Country Name City State
Egypt Tanta University Tanta El-Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The degree of pain The degree of pain will be evaluated using the numerical rating scale (NRS) from (0 to 10), zero means no pain and ten means the worst pain. It will be measured at PACU, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative. 48 hours postoperatively
Secondary Time of first analgesic Time of first analgesic will be measured from the end of surgery till first dose of morphine administrated. If numerical rating scale (NRS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia. 48 hours postoperatively
Secondary Total opioid consumption in 1st 48h A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. If numerical rating scale (NRS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia. 48 hours postoperatively
Secondary The degree of Patient satisfaction The degree of patient satisfaction will be assessed on a 5-point scale: (0= extremely dissatisfied, 1= unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied), 4= extremely satisfied). 48 hours postoperatively
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06075836 - AI Assisted Detection of Chest X-Rays
Completed NCT03572413 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis. Phase 4
Completed NCT03608436 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery Phase 4
Completed NCT04146090 - Low-pressure vs Standard-pressure in Laparoscopic Cholecystectomy N/A
Completed NCT02853591 - Comparison of Pneumoinsufflation Modes and Pressure Settings in Gynecology N/A
Completed NCT03576118 - Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy N/A
Completed NCT02079337 - Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery Phase 4
Completed NCT01512511 - Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy N/A
Not yet recruiting NCT06116383 - Evaluation of Renal Perfusion With NIRS in Laparoscopic Surgery
Withdrawn NCT03933254 - Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies
Recruiting NCT03069586 - Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain N/A
Recruiting NCT01867814 - Arterial and Plethysmographic Waveforms Variables as Predictors of Hemodynamic Response to Pneumoperitoneum N/A
Terminated NCT01854307 - The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements N/A
Recruiting NCT06447545 - Comparison Between Low Pressure Pneumoperitoneum With High Pressure Pneumoperitoneum in Post-operative Pain, Shoulder Tip Pain and Common Bile Duct Injuries in Patients Undergoing Laparoscopic Cholecystectomy N/A
Completed NCT05992636 - Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy
Completed NCT03957837 - Optical Nerve Sheath Changes During Head Down Laparoscopy
Recruiting NCT06319053 - The Turbine-based Insufflator Safety and Feasibility Study N/A
Completed NCT04125173 - Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy N/A
Not yet recruiting NCT02690688 - Intra-abdominal Pressure and Dynamic Preload Variables N/A
Completed NCT05238506 - Lidocaine VS Hemodynamic, Metabolic and Hormonal Response Phase 4