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The Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy

A Double-blinded, Randomized, Parallel Design Study to Compare the Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02100280
Acronym
suga-SH
Enrollment
96
Registered
2014-03-31
Start date
2014-06-29
Completion date
2017-06-16
Last updated
2024-01-10

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

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular blockade, Sugammadex, Laparoscopic surgery, IL-6

Brief summary

This study is a multicenter, randomized, controlled, double-blinded, and parallel design study. A total of 96 patients were decided to be recruited considering a 10% dropout rate. Patients are randomized to receive a deep block or a moderate block. The randomization numbers are generated using a computer-generated randomization code (1) and are sealed in the opaque envelope until they are handed over to the anesthesiologist in charge of anesthesia management after the induction of anesthesia. Patients, surgeons reporting the scale of surgical status, and another researcher analysing the cytokines levels are blinded to the patient group. Patients aged 18-65 yr, ASA 1 or 2, and are scheduled for elective laparoscopic gastrectomy are included. Patients with severe respiratory or cardiac disease, hepatic or renal function impairment, on medications affecting neuromuscular function, and with known allergy to the drugs to be used are excluded.

Detailed description

Induction and maintenance of anesthesia Premedication is done with midazolam 0.03 mg/kg IV at reception area. Anesthesia is induced and maintained with intravenous propofol, remifentanil, and rocuronium. The dose of propofol is adjusted to maintain BIS value to 40-60, remifentanil to maintain blood pressure within 20% of preoperative value, and rocuronium to maintain PTC 1-2 (deep block) or TOF1-2 (moderate block). The monitoring consists of ECG, NIBP, pulse oximetry, temperature, ETCO2, BIS, and neuromuscular monitoring with acceleromyography (TOF-Watch SXTM, Organon Ltd., Dublin, Ireland). Management and monitoring of neuromuscular block After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of PTC1-2 (deep block) or TOF1-2 (moderate block). At the end of surgery, sugammadex 4 mg/kg for deep block group or neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg for moderate block group are administered IV for reversal of neuromuscular block. Evaluation of surgical conditions A 5-point surgical rating scale (1 = excellent, 2 = good, 3 = acceptable, 4 = poor, 5 = extremely poor) is rated by the surgeon who is in charge of the patient's operation and is blind to the patient's group assignment. Intraoperative patient movement reported by surgeon, checked by restoration of spontaneous respiration or sudden increase in PIP, and any other movement are also recorded. Measurement of cytokines and acute phase reactants Blood samples are collected from the antecubital vein of the arm not used for IV infusion preoperatively, at the end of peritoneal closure, and 1, 2, & 48 hr after the end of operation for analysis of TNF-α, IL-1β, 6, 8 and CRP. The blood samples are collected at test tubes and sent to the laboratory on ice. Cytokines are analyzed with enzyme-linked immunosorbent assay and CRP is determined by an institutional chemistry analyzer. Postoperative pain measurement Postoperative pain is evaluated by verbal numerical rating scale (VNRS, 0 = no pain, 10 = the severest pain imaginable) at postoperative 1, 2, 6, 24, and 48 hr. Postoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician. The amount of fentanyl used and additional analgesic drugs used are reported.

Interventions

DRUGdeep block

sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists grade 1 or 2 * Scheduled for elective laparoscopic gastrectomy

Exclusion criteria

* Severe respiratory or cardiac disease * Severe hepatic or renal function impairment * On medications affecting neuromuscular function * Known allergy to the drugs to be used

Design outcomes

Primary

MeasureTime frameDescription
IL-61 hr after the end of operationBlood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 6.

Secondary

MeasureTime frameDescription
TNF-α30min before end of operationBlood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of TNF-α.
IL-1β30min before end of operationBlood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of IL-1β.
IL-81 hr after end of operationBlood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 8.
CRP48 hr after end of operationBlood samples are collected from the antecubital vein of the arm not used for IV infusion 48 hr after the end of operation for analysis of CRP.

Participant flow

Participants by arm

ArmCount
Deep Block
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block. deep block: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
48
Moderate Block
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
48
Total96

Baseline characteristics

CharacteristicDeep BlockModerate BlockTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
14 Participants9 Participants23 Participants
Age, Categorical
Between 18 and 65 years
34 Participants39 Participants73 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
48 Participants48 Participants96 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
14 Participants14 Participants28 Participants
Sex: Female, Male
Male
34 Participants34 Participants68 Participants
stress response44 Participants44 Participants88 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 440 / 44
other
Total, other adverse events
0 / 440 / 44
serious
Total, serious adverse events
0 / 440 / 44

Outcome results

Primary

IL-6

Blood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 6.

Time frame: 1 hr after the end of operation

ArmMeasureValue (MEAN)Dispersion
Deep BlockIL-684 pg / mlStandard Deviation 96.98
Moderate BlockIL-670.14 pg / mlStandard Deviation 99.15
Secondary

CRP

Blood samples are collected from the antecubital vein of the arm not used for IV infusion 48 hr after the end of operation for analysis of CRP.

Time frame: 48 hr after end of operation

ArmMeasureValue (MEAN)Dispersion
Deep BlockCRP12.2 pg / mlStandard Deviation 6.4
Moderate BlockCRP10.6 pg / mlStandard Deviation 5.6
Secondary

IL-1β

Blood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of IL-1β.

Time frame: 30min before end of operation

ArmMeasureValue (MEAN)Dispersion
Deep BlockIL-1β0.34 pg / mlStandard Deviation 0.55
Moderate BlockIL-1β0.27 pg / mlStandard Deviation 0.33
Secondary

IL-8

Blood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 8.

Time frame: 1 hr after end of operation

ArmMeasureValue (MEAN)Dispersion
Deep BlockIL-829.6 pg / mlStandard Deviation 13.9
Moderate BlockIL-829.5 pg / mlStandard Deviation 19.4
Secondary

TNF-α

Blood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of TNF-α.

Time frame: 30min before end of operation

ArmMeasureValue (MEAN)Dispersion
Deep BlockTNF-α1.33 pg / mlStandard Deviation 0.71
Moderate BlockTNF-α1.66 pg / mlStandard Deviation 1.75

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026