Deep Neuromuscular Blockade Improves Laparoscopic Surgical Conditions: A Randomized, Controlled Study

Jacob Rosenberg; W Joseph Herring; Manfred Blobner; Jan P Mulier; Niels Rahe-Meyer; Tiffany Woo; Michael K Li; Peter Grobara; Christopher A Assaid; Hein Fennema; Armin Szegedi

doi:10.1007/s12325-017-0495-x

Deep Neuromuscular Blockade Improves Laparoscopic Surgical Conditions: A Randomized, Controlled Study

Jacob Rosenberg, W Joseph Herring, Manfred Blobner, Jan P Mulier, Niels Rahe-Meyer, Tiffany Woo, Michael K Li, Peter Grobara, Christopher A Assaid, Hein Fennema, Armin Szegedi

Institut for Klinisk Medicin

25 Citationer (Scopus)

91 Downloads (Pure)

Abstract

Introduction: Sustained deep neuromuscular blockade (NMB) during laparoscopic surgery may facilitate optimal surgical conditions. This exploratory study assessed whether deep NMB improves surgical conditions and, in doing so, allows use of lower insufflation pressures during laparoscopic cholecystectomy. We further assessed whether use of low insufflation pressure improves patient pain scores after surgery. Methods: This randomized, controlled, blinded study (NCT01728584) compared use of deep (1–2 post-tetanic-counts) or moderate (train-of-four ratio 10%) NMB, and lower (8 mmHg) or higher (12 mmHg; ‘standard’) insufflation pressure in a 2 × 2 factorial design. Primary endpoint was surgeon’s overall satisfaction with surgical conditions, rated at end of surgery using an 11-point numerical scale. Post-operative pain scores were also evaluated. Data were analyzed using analysis of covariance. Results: Of 127 randomized patients, 120 had evaluable data for the primary endpoint. Surgeon’s score of overall satisfaction with surgical conditions was significantly higher with deep versus moderate NMB indicated by a least-square mean difference of 1.1 points (95% confidence interval 0.1–2.0; P = 0.026). Furthermore, strong evidence of an effect was observed for standard versus low pressure: least-square mean difference of 3.0 points (95% confidence interval 2.1–4.0; P < 0.001). No significant difference was observed in average pain scores within 24 h post-surgery for low versus standard pressure [0.17 (95% confidence interval −0.67 to +0.33); P = 0.494]. Conclusions: Although associated with significantly improved surgical conditions, deep NMB alone was insufficient to promote use of low insufflation pressure during laparoscopic cholecystectomy. Furthermore, low insufflation pressure did not result in reduced pain, compared with standard pressure. Clinical Trial Registration: ClinicalTrials.gov identifier, NCT01728584. Funding: Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Originalsprog	Engelsk
Tidsskrift	Advances in Therapy
Vol/bind	34
Udgave nummer	4
Sider (fra-til)	925-936
ISSN	0741-238X
DOI	https://doi.org/10.1007/s12325-017-0495-x
Status	Udgivet - 1 apr. 2017

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10.1007/s12325-017-0495-xLicens: CC BY-NC

10.1007_s12325-017-0495-xForlagets udgivne version, 506 KBLicens: CC BY-NC

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title = "Deep Neuromuscular Blockade Improves Laparoscopic Surgical Conditions: A Randomized, Controlled Study",

abstract = "Introduction: Sustained deep neuromuscular blockade (NMB) during laparoscopic surgery may facilitate optimal surgical conditions. This exploratory study assessed whether deep NMB improves surgical conditions and, in doing so, allows use of lower insufflation pressures during laparoscopic cholecystectomy. We further assessed whether use of low insufflation pressure improves patient pain scores after surgery. Methods: This randomized, controlled, blinded study (NCT01728584) compared use of deep (1–2 post-tetanic-counts) or moderate (train-of-four ratio 10%) NMB, and lower (8 mmHg) or higher (12 mmHg; {\textquoteleft}standard{\textquoteright}) insufflation pressure in a 2 × 2 factorial design. Primary endpoint was surgeon{\textquoteright}s overall satisfaction with surgical conditions, rated at end of surgery using an 11-point numerical scale. Post-operative pain scores were also evaluated. Data were analyzed using analysis of covariance. Results: Of 127 randomized patients, 120 had evaluable data for the primary endpoint. Surgeon{\textquoteright}s score of overall satisfaction with surgical conditions was significantly higher with deep versus moderate NMB indicated by a least-square mean difference of 1.1 points (95% confidence interval 0.1–2.0; P = 0.026). Furthermore, strong evidence of an effect was observed for standard versus low pressure: least-square mean difference of 3.0 points (95% confidence interval 2.1–4.0; P < 0.001). No significant difference was observed in average pain scores within 24 h post-surgery for low versus standard pressure [0.17 (95% confidence interval −0.67 to +0.33); P = 0.494]. Conclusions: Although associated with significantly improved surgical conditions, deep NMB alone was insufficient to promote use of low insufflation pressure during laparoscopic cholecystectomy. Furthermore, low insufflation pressure did not result in reduced pain, compared with standard pressure. Clinical Trial Registration: ClinicalTrials.gov identifier, NCT01728584. Funding: Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.",

keywords = "Adult, Cholecystectomy, Laparoscopic/methods, Female, Humans, Male, Middle Aged, Neuromuscular Blockade/methods, Pain, Postoperative/epidemiology, Single-Blind Method",

author = "Jacob Rosenberg and Herring, {W Joseph} and Manfred Blobner and Mulier, {Jan P} and Niels Rahe-Meyer and Tiffany Woo and Li, {Michael K} and Peter Grobara and Assaid, {Christopher A} and Hein Fennema and Armin Szegedi",

year = "2017",

month = apr,

day = "1",

doi = "10.1007/s12325-017-0495-x",

language = "English",

volume = "34",

pages = "925--936",

journal = "Advances in Therapy",

issn = "0741-238X",

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number = "4",

}

TY - JOUR

T1 - Deep Neuromuscular Blockade Improves Laparoscopic Surgical Conditions

T2 - A Randomized, Controlled Study

AU - Rosenberg, Jacob

AU - Herring, W Joseph

AU - Blobner, Manfred

AU - Mulier, Jan P

AU - Rahe-Meyer, Niels

AU - Woo, Tiffany

AU - Li, Michael K

AU - Grobara, Peter

AU - Assaid, Christopher A

AU - Fennema, Hein

AU - Szegedi, Armin

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Introduction: Sustained deep neuromuscular blockade (NMB) during laparoscopic surgery may facilitate optimal surgical conditions. This exploratory study assessed whether deep NMB improves surgical conditions and, in doing so, allows use of lower insufflation pressures during laparoscopic cholecystectomy. We further assessed whether use of low insufflation pressure improves patient pain scores after surgery. Methods: This randomized, controlled, blinded study (NCT01728584) compared use of deep (1–2 post-tetanic-counts) or moderate (train-of-four ratio 10%) NMB, and lower (8 mmHg) or higher (12 mmHg; ‘standard’) insufflation pressure in a 2 × 2 factorial design. Primary endpoint was surgeon’s overall satisfaction with surgical conditions, rated at end of surgery using an 11-point numerical scale. Post-operative pain scores were also evaluated. Data were analyzed using analysis of covariance. Results: Of 127 randomized patients, 120 had evaluable data for the primary endpoint. Surgeon’s score of overall satisfaction with surgical conditions was significantly higher with deep versus moderate NMB indicated by a least-square mean difference of 1.1 points (95% confidence interval 0.1–2.0; P = 0.026). Furthermore, strong evidence of an effect was observed for standard versus low pressure: least-square mean difference of 3.0 points (95% confidence interval 2.1–4.0; P < 0.001). No significant difference was observed in average pain scores within 24 h post-surgery for low versus standard pressure [0.17 (95% confidence interval −0.67 to +0.33); P = 0.494]. Conclusions: Although associated with significantly improved surgical conditions, deep NMB alone was insufficient to promote use of low insufflation pressure during laparoscopic cholecystectomy. Furthermore, low insufflation pressure did not result in reduced pain, compared with standard pressure. Clinical Trial Registration: ClinicalTrials.gov identifier, NCT01728584. Funding: Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

AB - Introduction: Sustained deep neuromuscular blockade (NMB) during laparoscopic surgery may facilitate optimal surgical conditions. This exploratory study assessed whether deep NMB improves surgical conditions and, in doing so, allows use of lower insufflation pressures during laparoscopic cholecystectomy. We further assessed whether use of low insufflation pressure improves patient pain scores after surgery. Methods: This randomized, controlled, blinded study (NCT01728584) compared use of deep (1–2 post-tetanic-counts) or moderate (train-of-four ratio 10%) NMB, and lower (8 mmHg) or higher (12 mmHg; ‘standard’) insufflation pressure in a 2 × 2 factorial design. Primary endpoint was surgeon’s overall satisfaction with surgical conditions, rated at end of surgery using an 11-point numerical scale. Post-operative pain scores were also evaluated. Data were analyzed using analysis of covariance. Results: Of 127 randomized patients, 120 had evaluable data for the primary endpoint. Surgeon’s score of overall satisfaction with surgical conditions was significantly higher with deep versus moderate NMB indicated by a least-square mean difference of 1.1 points (95% confidence interval 0.1–2.0; P = 0.026). Furthermore, strong evidence of an effect was observed for standard versus low pressure: least-square mean difference of 3.0 points (95% confidence interval 2.1–4.0; P < 0.001). No significant difference was observed in average pain scores within 24 h post-surgery for low versus standard pressure [0.17 (95% confidence interval −0.67 to +0.33); P = 0.494]. Conclusions: Although associated with significantly improved surgical conditions, deep NMB alone was insufficient to promote use of low insufflation pressure during laparoscopic cholecystectomy. Furthermore, low insufflation pressure did not result in reduced pain, compared with standard pressure. Clinical Trial Registration: ClinicalTrials.gov identifier, NCT01728584. Funding: Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

KW - Adult

KW - Cholecystectomy, Laparoscopic/methods

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Neuromuscular Blockade/methods

KW - Pain, Postoperative/epidemiology

KW - Single-Blind Method

U2 - 10.1007/s12325-017-0495-x

DO - 10.1007/s12325-017-0495-x

M3 - Journal article

C2 - 28251555

SN - 0741-238X

VL - 34

SP - 925

EP - 936

JO - Advances in Therapy

JF - Advances in Therapy

IS - 4

ER -

Deep Neuromuscular Blockade Improves Laparoscopic Surgical Conditions: A Randomized, Controlled Study

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