Gynecologic DiseaseNCT05689957
Moderate vs Deep Neuromuscular Block in Lower Pressure Pneumoperitoneum
A study testing Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular block in people with Gynecologic Disease and Neuromuscular Blockade, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The investigators hypothesized that deep neuromuscular block compare to moderate neuromuscular block would reduce the rate of increasing intraabdominal pressure and operation can be completely done in lower pressure pneumoperitoneum and would improve laparoscopic space by measuring distance from the sacral promontory… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Disease, Neuromuscular Blockade
- What is being tested?
- Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMalaysia
- Study dates
- 13 Dec 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age more than 18 years old
- ASA I or II
- schedule to undergo laparoscopic gynaecological surgery (laparoscopic hysterectomy and laparoscopic ovarian cystectomy in Hospital Universiti Sains Malaysia , Kubang Kerian, Kelantan
Who cannot join
- Allergy to study drugs (rocuronium, suggamadex)
- Serious cardiac and respiratory disease (reactive airway disease, upper respiratory tract infection)
- Neurological or neuromuscular disease (epilepsy, family history and history of malignant hyperthermia etc.)
- Pregnancy
- Morbid obesity BMI>35
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University of Science Malaysia Hospital
Kubang Kerian, Kelantan, 16150
About this study
Official title: Evaluation of Surgical Condition During Laparoscopic Gynaecological Surgery in Patient With Moderate vs Deep Neuromuscular Block in Lower Pressure Pneumoperitoneum
The investigators hypothesized that deep neuromuscular block compare to moderate neuromuscular block would reduce the rate of increasing intraabdominal pressure and operation can be completely done in lower pressure pneumoperitoneum and would improve laparoscopic space by measuring distance from the sacral promontory to the inserted trocar in patients undergoing laparoscopic gynaecological surgery.
Read the detailed description
Laparoscopic surgery has increasing popularity and slowly replacing conventional open surgery as it offers more benefit to patient and health care practitioner. The overall risk of complications during laparoscopic surgery is recognized to be lower than during laparotomy. Laparoscopic hysterectomy compare to open vaginal hysterectomy reduces postoperative pain, reduce post op analgesics requirement and shorter duration of hospital admission.1 However, the increase intra-abdominal pressure created during laparoscopic surgery can affect cardiovascular, pulmonary and renal physiology. Besides the risk of post-operative nausea and vomiting, it is also stated that the pneumoperitoneum created during laparoscopic surgery is an important factor in the cause of postoperative shoulder pain.2 Traditionally pneumoperitoneum created at 15mmHg3. Insufflation of intraabdominal carbon dioxide may cause post-operative shoulder pain up to 70% in some study in gynaecologic laparoscopic surgery. 4 Use a lower pressure pneumoperitoneum might decrease postoperative pain, decrease post-operative shoulder tip pain5 and reduce the risk of laparoscopic related complication6. Many studies used lower insufflation of intraabdominal pressure as an intraoperative intervention to reduce the complication7,8. However, a lower intraabdominal pressure may worsen surgical space and increase the risk of conversion to open surgery.
Though many factors contribute to the quality of surgical space include non-modifiable such as obesity, previous abdominal surgery and modifiable factors such as anaesthesia related factor, patient position and intraabdominal pressure. Numerous studies also have been carried out showing that deep neuromuscular block improves surgical condition in different type of laparoscopic surgery includes robotic assisted laparoscopic surgery.9,10,11 Currently with the advancement of technology where neuromuscular monitoring is widely available and the selective reversal binding agent suggamadex where post-operative complication of inadequate reversal can be markedly reduced, several studies have been done to observe the benefit of low intraabdominal pressure with deep neuromuscular block to surgical space quality and intraoperative complication related to high pressure intraabdominal complication compare to usual moderate block.9,10,12 However there is still few study objectively measure the possible effect of deep neuromuscular blocker on the surgical space and the ability of surgery to be completely done in low pressure pneumoperitoneum in laparoscopic gynaecological surgery.
This study will compare the rate of increasing intraabdominal pressure, skin to sacral promontary distance, and post operative pain between deep neuromuscular block and moderate neuromuscular block.
- Conditions
- Gynecologic Disease, Neuromuscular Blockade
- Being tested
- Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular block
- Keywords
- deep neuromuscular block, low pressure pneumoperitoneum, laparoscopic gynaecological surgery
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular blockDrug
both arm are using low pressure pneumoperitoneum in laparoscopic surgery, moderate and deep neuromuscular block are monitor with neuromuscular monitoring. if surgical condition is inadequate, surgeon are allowed to increase intraabdominal pressure as per standard care
| Study group | Role | What they receive |
|---|---|---|
| deep neuromuscular block group | Experimental | Group 1 (Induction with Rocuronium 0.6mg/kg + maintenance with intravenous Rocuronium rocuronium 8-12mcg/kg/minute (0.48-0.72 mg/kg/hour maintain PTC 0-1(deep block). (Study Group) intraoperatively Receives: Drug: Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular block |
| moderate neuromuscular block group | Active comparator | Group 2 (Induction with intravenous Rocuronium 0.6mg/kg + maintenance with intermittent intravenous Rocuronium 0.2mg/kg bolus. maintain PTC >1, TOF 0-2). Moderate block. (Control Group) intraoperatively Receives: Drug: Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adequacy of intraabdominal pressure in mmHg
- To compare the rate of increasing intra-abdominal pressure (IAP) by the surgeon when they decide that the surgical conditions are inadequate for the operation in patient receiving deep neuromuscular block compare to moderate neuromuscular block in laparoscopic gynaecological surgery
Measured: intraoperative
Secondary outcomes (4)
The quality of surgical space
- To compare quality of surgical space condition in patient receiving deep and moderate neuromuscular block in laparoscopic gynaecological surgery.
Measured: intraoperative
the distance between the skin to sacral promontary in centimetres (cm)
- To compare skin to sacral promontory distance in patient in patient receiving moderate neuromuscular block and deep neuromuscular block in laparoscopic gynaecological surgery.
Measured: intaoperative
post operative pain
To compare the post-operative pain and shoulder tip pain in patient receiving deep neuromuscular block and moderate neuromuscular block in laparoscopic gynaecological surgery by using visual analog pain score (VAS)
Measured: 24 hour post operation
shoulder tip pain using pain visual analogue score (VAS)
To compare shoulder tip pain in patient receiving deep neuromuscular block and moderate neuromuscular block in laparoscopic gynaecological surgery by using visual analog pain score (VAS)
Measured: 24 hour post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start13 Dec 2020
- Primary completion13 Dec 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rhendra Hardy Mohamad Zaini, Universiti Sains Malaysia
- Investigators
- Umairah Esa, MBBS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689957
- Sponsor's protocol ID
- USM/JEPeM/20080410
- Status last verified
- Jan 2023
- First submitted
- 30 Dec 2020
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ghezzi F, Uccella S, Cromi A, Siesto G, Serati M, Bogani G, Bolis P. Postoperative pain after laparoscopic and vaginal hysterectomy for benign gynecologic disease: a randomized trial. Am J Obstet Gynecol. 2010 Aug;203(2):118.e1-8. doi: 10.1016/j.ajog.2010.04.026. Epub 2010 Jun 3.
PubMed 20522410Madsen MV, Istre O, Staehr-Rye AK, Springborg HH, Rosenberg J, Lund J, Gatke MR. Postoperative shoulder pain after laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure pneumoperitoneum: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):341-7. doi: 10.1097/EJA.0000000000000360.
PubMed 26479510Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.
PubMed 24503370Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
PubMed 22184293Bogani G, Uccella S, Cromi A, Serati M, Casarin J, Pinelli C, Ghezzi F. Low vs standard pneumoperitoneum pressure during laparoscopic hysterectomy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):466-71. doi: 10.1016/j.jmig.2013.12.091. Epub 2013 Dec 25.
PubMed 24374246Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs Standard Pressures in Gynecologic Laparoscopy: a Systematic Review. JSLS. 2016 Jan-Mar;20(1):e2015.00113. doi: 10.4293/JSLS.2015.00113.
PubMed 26955258Donatsky AM, Bjerrum F, Gogenur I. Surgical techniques to minimize shoulder pain after laparoscopic cholecystectomy. A systematic review. Surg Endosc. 2013 Jul;27(7):2275-82. doi: 10.1007/s00464-012-2759-5. Epub 2013 Jan 24.
PubMed 23340814Kim MH, Lee KY, Lee KY, Min BS, Yoo YC. Maintaining Optimal Surgical Conditions With Low Insufflation Pressures is Possible With Deep Neuromuscular Blockade During Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-Blind, Parallel-Group Clinical Trial. Medicine (Baltimore). 2016 Mar;95(9):e2920. doi: 10.1097/MD.0000000000002920.
PubMed 26945393Koo BW, Oh AY, Seo KS, Han JW, Han HS, Yoon YS. Randomized Clinical Trial of Moderate Versus Deep Neuromuscular Block for Low-Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy. World J Surg. 2016 Dec;40(12):2898-2903. doi: 10.1007/s00268-016-3633-8.
PubMed 27405749Madsen MV, Gatke MR, Springborg HH, Rosenberg J, Lund J, Istre O. Optimising abdominal space with deep neuromuscular blockade in gynaecologic laparoscopy--a randomised, blinded crossover study. Acta Anaesthesiol Scand. 2015 Apr;59(4):441-7. doi: 10.1111/aas.12493. Epub 2015 Mar 1.
PubMed 25789421Ozdemir-van Brunschot DMD, Braat AE, van der Jagt MFP, Scheffer GJ, Martini CH, Langenhuijsen JF, Dam RE, Huurman VA, Lam D, d'Ancona FC, Dahan A, Warle MC. Deep neuromuscular blockade improves surgical conditions during low-pressure pneumoperitoneum laparoscopic donor nephrectomy. Surg Endosc. 2018 Jan;32(1):245-251. doi: 10.1007/s00464-017-5670-2. Epub 2017 Jun 22.
PubMed 28643056Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.
PubMed 24809482Bruintjes MH, van Helden EV, Braat AE, Dahan A, Scheffer GJ, van Laarhoven CJ, Warle MC. Deep neuromuscular block to optimize surgical space conditions during laparoscopic surgery: a systematic review and meta-analysis. Br J Anaesth. 2017 Jun 1;118(6):834-842. doi: 10.1093/bja/aex116.
PubMed 28575335Park SK, Son YG, Yoo S, Lim T, Kim WH, Kim JT. Deep vs. moderate neuromuscular blockade during laparoscopic surgery: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Nov;35(11):867-875. doi: 10.1097/EJA.0000000000000884.
PubMed 30188357Wei Y, Li J, Sun F, Zhang D, Li M, Zuo Y. Low intra-abdominal pressure and deep neuromuscular blockade laparoscopic surgery and surgical space conditions: A meta-analysis. Medicine (Baltimore). 2020 Feb;99(9):e19323. doi: 10.1097/MD.0000000000019323.
PubMed 32118762
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Condition During Laparoscopic Gynaecological Surgery in Patient With Moderate vs Deep Neuromuscular Block in Lower Pressure Pneumoperitoneum
- ClinicalTrials.gov ID
- NCT05689957
- Acronym / sponsor ID
- USM/JEPeM/20080410
- Conditions
- Gynecologic Disease, Neuromuscular Blockade
- Keywords
- deep neuromuscular block, low pressure pneumoperitoneum, laparoscopic gynaecological surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesized that deep neuromuscular block compare to moderate neuromuscular block would reduce the rate of increasing intraabdominal pressure and operation can be completely done in lower pressure pneumoperitoneum and would improve laparoscopic space by measuring distance from the sacral promontory to the inserted trocar in patients undergoing laparoscopic gynaecological surgery.
Detailed description
Laparoscopic surgery has increasing popularity and slowly replacing conventional open surgery as it offers more benefit to patient and health care practitioner. The overall risk of complications during laparoscopic surgery is recognized to be lower than during laparotomy. Laparoscopic hysterectomy compare to open vaginal hysterectomy reduces postoperative pain, reduce post op analgesics requirement and shorter duration of hospital admission.1 However, the increase intra-abdominal pressure created during laparoscopic surgery can affect cardiovascular, pulmonary and renal physiology. Besides the risk of post-operative nausea and vomiting, it is also stated that the pneumoperitoneum created during laparoscopic surgery is an important factor in the cause of postoperative shoulder pain.2 Traditionally pneumoperitoneum created at 15mmHg3. Insufflation of intraabdominal carbon dioxide may cause post-operative shoulder pain up to 70% in some study in gynaecologic laparoscopic surgery. 4 Use a lower pressure pneumoperitoneum might decrease postoperative pain, decrease post-operative shoulder tip pain5 and reduce the risk of laparoscopic related complication6. Many studies used lower insufflation of intraabdominal pressure as an intraoperative intervention to reduce the complication7,8. However, a lower intraabdominal pressure may worsen surgical space and increase the risk of conversion to open surgery.
Though many factors contribute to the quality of surgical space include non-modifiable such as obesity, previous abdominal surgery and modifiable factors such as anaesthesia related factor, patient position and intraabdominal pressure. Numerous studies also have been carried out showing that deep neuromuscular block improves surgical condition in different type of laparoscopic surgery includes robotic assisted laparoscopic surgery.9,10,11 Currently with the advancement of technology where neuromuscular monitoring is widely available and the selective reversal binding agent suggamadex where post-operative complication of inadequate reversal can be markedly reduced, several studies have been done to observe the benefit of low intraabdominal pressure with deep neuromuscular block to surgical space quality and intraoperative complication related to high pressure intraabdominal complication compare to usual moderate block.9,10,12 However there is still few study objectively measure the possible effect of deep neuromuscular blocker on the surgical space and the ability of surgery to be completely done in low pressure pneumoperitoneum in laparoscopic gynaecological surgery.
This study will compare the rate of increasing intraabdominal pressure, skin to sacral promontary distance, and post operative pain between deep neuromuscular block and moderate neuromuscular block.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep neuromuscular block group | Experimental | Drug: Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular blockGroup 1 (Induction with Rocuronium 0.6mg/kg + maintenance with intravenous Rocuronium rocuronium 8-12mcg/kg/minute (0.48-0.72 mg/kg/hour maintain PTC 0-1(deep block). (Study Group) intraoperatively |
| moderate neuromuscular block group | Active comparator | Drug: Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular blockGroup 2 (Induction with intravenous Rocuronium 0.6mg/kg + maintenance with intermittent intravenous Rocuronium 0.2mg/kg bolus. maintain PTC >1, TOF 0-2). Moderate block. (Control Group) intraoperatively |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 18 years old
- ASA I or II
- schedule to undergo laparoscopic gynaecological surgery (laparoscopic hysterectomy and laparoscopic ovarian cystectomy in Hospital Universiti Sains Malaysia , Kubang Kerian, Kelantan
Key exclusion criteria (5 listed)
- Allergy to study drugs (rocuronium, suggamadex)
- Serious cardiac and respiratory disease (reactive airway disease, upper respiratory tract infection)
- Neurological or neuromuscular disease (epilepsy, family history and history of malignant hyperthermia etc.)
- Pregnancy
- Morbid obesity BMI>35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular blockboth arm are using low pressure pneumoperitoneum in laparoscopic surgery, moderate and deep neuromuscular block are monitor with neuromuscular monitoring. if surgical condition is inadequate, surgeon are allowed to increase intraabdominal pressure as per standard care | Drug | deep neuromuscular block group, moderate neuromuscular block group |
Primary outcome
The adequacy of intraabdominal pressure in mmHg
Time frame: intraoperative
1. To compare the rate of increasing intra-abdominal pressure (IAP) by the surgeon when they decide that the surgical conditions are inadequate for the operation in patient receiving deep neuromuscular block compare to moderate neuromuscular block in laparoscopic gynaecological surgery
4 secondary outcomes
The quality of surgical space
Time frame: intraoperative
the distance between the skin to sacral promontary in centimetres (cm)
Time frame: intaoperative
post operative pain
Time frame: 24 hour post operation
shoulder tip pain using pain visual analogue score (VAS)
Time frame: 24 hour post operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 20522410Ghezzi F, Uccella S, Cromi A, Siesto G, Serati M, Bogani G, Bolis P. Postoperative pain after laparoscopic and vaginal hysterectomy for benign gynecologic disease: a randomized trial. Am J Obstet Gynecol. 2010 Aug;203(2):118.e1-8. doi: 10.1016/j.ajog.2010.04.026. Epub 2010 Jun 3.
- Background: PubMed 26479510Madsen MV, Istre O, Staehr-Rye AK, Springborg HH, Rosenberg J, Lund J, Gatke MR. Postoperative shoulder pain after laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure pneumoperitoneum: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):341-7. doi: 10.1097/EJA.0000000000000360.
- Background: PubMed 24503370Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.
- Background: PubMed 22184293Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
- Background: PubMed 24374246Bogani G, Uccella S, Cromi A, Serati M, Casarin J, Pinelli C, Ghezzi F. Low vs standard pneumoperitoneum pressure during laparoscopic hysterectomy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):466-71. doi: 10.1016/j.jmig.2013.12.091. Epub 2013 Dec 25.
- Background: PubMed 26955258Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs Standard Pressures in Gynecologic Laparoscopy: a Systematic Review. JSLS. 2016 Jan-Mar;20(1):e2015.00113. doi: 10.4293/JSLS.2015.00113.
- Background: PubMed 23340814Donatsky AM, Bjerrum F, Gogenur I. Surgical techniques to minimize shoulder pain after laparoscopic cholecystectomy. A systematic review. Surg Endosc. 2013 Jul;27(7):2275-82. doi: 10.1007/s00464-012-2759-5. Epub 2013 Jan 24.
- Background: PubMed 26945393Kim MH, Lee KY, Lee KY, Min BS, Yoo YC. Maintaining Optimal Surgical Conditions With Low Insufflation Pressures is Possible With Deep Neuromuscular Blockade During Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-Blind, Parallel-Group Clinical Trial. Medicine (Baltimore). 2016 Mar;95(9):e2920. doi: 10.1097/MD.0000000000002920.
- Background: PubMed 27405749Koo BW, Oh AY, Seo KS, Han JW, Han HS, Yoon YS. Randomized Clinical Trial of Moderate Versus Deep Neuromuscular Block for Low-Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy. World J Surg. 2016 Dec;40(12):2898-2903. doi: 10.1007/s00268-016-3633-8.
- Background: PubMed 25789421Madsen MV, Gatke MR, Springborg HH, Rosenberg J, Lund J, Istre O. Optimising abdominal space with deep neuromuscular blockade in gynaecologic laparoscopy--a randomised, blinded crossover study. Acta Anaesthesiol Scand. 2015 Apr;59(4):441-7. doi: 10.1111/aas.12493. Epub 2015 Mar 1.
- Background: PubMed 28643056Ozdemir-van Brunschot DMD, Braat AE, van der Jagt MFP, Scheffer GJ, Martini CH, Langenhuijsen JF, Dam RE, Huurman VA, Lam D, d'Ancona FC, Dahan A, Warle MC. Deep neuromuscular blockade improves surgical conditions during low-pressure pneumoperitoneum laparoscopic donor nephrectomy. Surg Endosc. 2018 Jan;32(1):245-251. doi: 10.1007/s00464-017-5670-2. Epub 2017 Jun 22.
- Background: PubMed 24809482Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umairah Esa, MBBS principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep neuromuscular block using intravenous rocuronium induction at 1.2mg/kg and maintainance of 8-12mcg/kg/min for deep neuromuscular block in people with Gynecologic Disease and Neuromuscular Blockade, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adequacy of intraabdominal pressure in mmHg (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05689957, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.